FDA Oncology @FDAOncology Twitter profile

Last Seen Profiles

@Keharward

@BoomerMays

@pajakmdybogor

@BollAndBranch

@yuzuisacutie

@Astro_Mike

@BoysLoveBuzz

@01familia_info

@Theerayut494174

@CloudedAshes

@Akadem_Campus

@BakbakEnt

@BeerlySports

@AytoBarbastro

@wotantyshirt

@yodominguez

@BasicAshHoe

@Ai_lchemist

@BANGCHAN_INTL

@AyakaOhashi

@david_colquhoun

@BSCS_Global

@yonaka_nemu

@BlackGenet

@cweamcat

@DEVIANT_STAFF

@NCastellers

@Yix_B0y

@raykar57

@MidvaleMarcus

@jiarvs

@love4llthotties

@tannermurrayy

@legisver

@yuccheeyy

@NgCharaOfTheDay

FDA Oncology

@FDAOncology

5 years

2018 saw 32 #FDAapprovals in #hematology including 12 NMEs & 5 #biosimilars . 8 had pediatric indications. 6 were for 1st-line indications. We used the Real-Time Oncology Review to approve brentuximab vedotin 2 wks after receiving the company's completed application. #ASH18

4

182

246

FDA Oncology

@FDAOncology

5 years

Today, FDA approved pembrolizumab plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma

0

159

207

FDA Oncology

@FDAOncology

4 years

Today, FDA approved pembrolizumab (KEYTRUDA, Merck) for patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ with/without papillary tumors who are ineligible for or elected not to undergo cystectomy #blcsm

6

104

137

FDA Oncology

@FDAOncology

6 years

2017 a banner year for FDA approvals in hematologic malignancies. In this graphic, purple=4 new drug approvals for AML; red=5 new drugs for ALL/NHL; orange=supplemental approvals for new indications #ASH17

1

113

131

FDA Oncology

@FDAOncology

4 years

Today FDA granted accelerated approval to a new dosing regimen of 400 mg every six weeks for pembrolizumab (KEYTRUDA®, Merck) across all currently approved adult indications, in addition to the current 200 mg every three weeks dosing regimen

3

73

114

FDA Oncology

@FDAOncology

5 years

FDA granted accelerated approval to larotrectinib for treatment of certain patients with solid tumors with NTRK gene fusion without a known acquired resistance mutation. See drug label for details:

0

68

104

FDA Oncology

@FDAOncology

3 years

FDA approved osimertinib (TAGRISSO, AstraZeneca) for adjuvant therapy after tumor resection in patients with non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations as detected by an FDA-approved test. #lcsm

0

50

110

FDA Oncology

@FDAOncology

4 years

FDA today published 4 final guidances on #cancer #clinicaltrial eligibility criteria, describing ways that drug sponsors can safely and effectively include patients who historically have been excluded from trials.

8

59

109

FDA Oncology

@FDAOncology

4 years

On June 15, FDA granted accelerated approval to lurbinectedin (ZEPZELCA, Pharma Mar SA) for adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. #lcsm Drug label:

5

66

105

FDA Oncology

@FDAOncology

5 years

FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative #breastcancer . #bcsm Drug label:

2

41

104

FDA Oncology

@FDAOncology

4 years

FDA approved nivolumab+ipilimumab (OPDIVO+YERVOY, BMS) as 1st-line treatment for patients w/metastatic NSCLC expressing PD-L1(≥1%), as determined by an FDA-approved test, w/ no EGFR or ALK genomic tumor aberrations. (CDx also approved.)

2

47

105

FDA Oncology

@FDAOncology

2 years

The @WhiteHouse reignited the #CancerMoonshot to end cancer as we know it today. How? -Prevention & early cancer detection -Addressing inequities in the health care system -Improving treatments -Supporting & learning from patients and caregivers

Fact Sheet: President Biden Reignites Cancer Moonshot to End Cancer as We Know It | The White House

Biden-Harris Administration Sets Goal of Reducing Cancer Death Rate by at least 50 Percent Over the Next 25 Years, and Improving the Experience of Living with and Surviving Cancer As Vice President,...

www.whitehouse.gov

6

31

100

FDA Oncology

@FDAOncology

8 months

Today, FDA issued final guidance, "Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products." #RWD #RWE #drugdevelopment #FDAGuidance

Considerations for the Use of Real-World Data and Real-World Evidence

CMC

www.fda.gov

11

27

102

FDA Oncology

@FDAOncology

2 years

FDA granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen) the 1st bispecific B-cell maturation antigen-directed CD3 T-cell engager for relapsed/refractory multiple myeloma after 4 prior lines of therapy. #OCENewsBurst

FDA approves teclistamab-cqyv for relapsed or refractory multiple myel

On October 25, 2022, the Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen (BCMA)-direc...

www.fda.gov

1

45

100

FDA Oncology

@FDAOncology

2 years

FDA approved nivolumab (Opdivo, BMS) with platinum-doublet chemotherapy for resectable non-small cell lung cancer in the neoadjuvant setting. This represents the first FDA approval for neoadjuvant therapy for early-stage NSCLC. #OCENewsBurst

FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy

FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer

www.fda.gov

4

41

98

FDA Oncology

@FDAOncology

5 years

On May 3, FDA approved ado-trastuzumab emtansine (KADCYLA, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment #bcsm

2

51

94

FDA Oncology

@FDAOncology

1 month

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. #OCENewsBurst

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for

On April 5, 2024, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic...

www.fda.gov

1

57

91

FDA Oncology

@FDAOncology

3 years

Read about FDA approvals from 2010-2020 for the treatment of breast malignancies and their relevant clinical trials, endpoints, and regulatory considerations - via @CCR_AACR . Important article by our breast cancer team in Division of Oncology 1! #bcsm

2

45

94

FDA Oncology

@FDAOncology

4 years

FDA approved Retevmo (selpercatinib) to treat non-small cell lung cancer and thyroid cancers in patients whose tumors have a RET gene mutation or fusion. Retevmo is the 1st therapy approved specifically for cancer with RET gene alterations. #lcsm #thycsm

1

51

87

FDA Oncology

@FDAOncology

3 years

FDA granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.

1

37

90

FDA Oncology

@FDAOncology

4 months

FDA approves pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.

FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage

On January 12, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.

www.fda.gov

1

46

88

FDA Oncology

@FDAOncology

3 years

FDA grants accelerated approval to pembrolizumab (KEYTRUDA, Merck) in combination w/chemotherapy for treatment of patients w/ locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1. #bcsm

0

44

74

FDA Oncology

@FDAOncology

5 years

FDA grants accelerated approval to atezolizumab (TECENTRIQ®, Genentech Inc.) in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1

0

53

77

FDA Oncology

@FDAOncology

4 years

#FDAOncology wishes @BlumenthalG well as he leaves FDA for a new role. Dr. Blumenthal has had a large impact in cancer research & regulatory science and was a well-respected leader for oncology during his 14+ years of government service at FDA and NIH.

4

16

75

FDA Oncology

@FDAOncology

3 years

Happy Thanksgiving from all of us at #FDAOncology !

5

6

72

FDA Oncology

@FDAOncology

2 years

We welcomed 66 #OncTwitter fellows to a hybrid @FDAOncology - @ASCO Fellows Day Workshop, now in its 7th year. Thank you, fellows! It was great seeing you in person or virtually. @realrickpazdur @tmprowell @drjennifergao @SuparnaWedam #OCEProjectSocrates #regulatory #MedEd

2

16

72

FDA Oncology

@FDAOncology

4 years

It was a pleasure hosting the @ASCO Leadership Development Program today! We talked about what leadership is, our work and projects—and received some good suggestions from these rising leaders in oncology. Thanks for visiting us #asco_ldp ! @realrickpazdur @drjennifergao

1

9

72

FDA Oncology

@FDAOncology

5 years

OCE Director Richard Pazdur, MD, @realrickpazdur welcomed oncology fellows today for #FDA_ASCOFellowsDay on the FDA campus at White Oak with some of the faculty: @drjennifergao @tmprowell @LalehAmiri @KellyNorsworth2 and Suparna Wedam. #MedEd

1

15

71

FDA Oncology

@FDAOncology

3 years

The Division of Oncology 1, FDA Office of Oncologic Diseases, hosted a retreat today at Cabin John Park, Bethesda, MD. It was a beautiful day and fantastic to see everyone in person. @realrickpazdur made it official with the obligatory selfie!

2

7

70

FDA Oncology

@FDAOncology

4 years

#FDAOncology stands in solidarity with patients with cancer and all communities experiencing distress and pain from events of the past week. Our diverse staff is committed to supporting #equity and #inclusion in healthcare and disavows all forms of discrimination. -Richard Pazdur

1

31

69

FDA Oncology

@FDAOncology

3 years

FDA approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma (RCC).

FDA approves nivolumab plus cabozantinib for advanced renal cell carci

Hematology / Oncology News Burst

www.fda.gov

1

31

66

FDA Oncology

@FDAOncology

4 years

FDA granted accelerated approval to sacituzumab govitecan-hziy for patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease. #bcsm Drug label:

1

32

66

FDA Oncology

@FDAOncology

10 months

FDA approves quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation for newly diagnosed acute myeloid leukemia ( #AML ). Drug label:

3

27

65

FDA Oncology

@FDAOncology

6 years

#FDA approval: First FDA-approved treatment for patients with germline BRCA-mutated metastatic HER2-negative metastatic #breastcancer . FDA also expanded approval of BRACAnalysis CDx test

0

57

62

FDA Oncology

@FDAOncology

6 years

2017 a banner year for FDA approvals in hematologic malignancies. In this graphic, purple=4 new drug approvals for AML; red=5 new drugs for ALL/NHL; orange=supplemental approvals for new indications #ASH17

3

46

63

FDA Oncology

@FDAOncology

3 years

Update to FDA guidance affirms that people who received #COVID19 #vaccine or any product under emergency use (EUA) are not considered by FDA to have received an investigational product and shouldn't be excluded from #clinicaltrials for that reason: See

1

40

62

FDA Oncology

@FDAOncology

4 years

#FDAOncology review teams are busier than ever, with 8 approvals so far in May. Track #oncology #drugapprovals here.

0

21

65

FDA Oncology

@FDAOncology

4 years

Today the FDA approved the combination of nivolumab plus ipilimumab as first-line treatment for adult patients with unresectable malignant pleural #mesothelioma

0

31

64

FDA Oncology

@FDAOncology

3 years

FDA approved atezolizumab (Tecentriq, Genentech) for adjuvant treatment following resection and platinum-based chemotherapy stage II-IIIA NSCLC with PD-L1 expression on ≥1% of tumor cells. FDA also approved VENTANA PD-L1 (SP263) Assay as a CDx. #lcsm

FDA approves atezolizumab as adjuvant treatment for non-small cell lun

Oncology News Burst

www.fda.gov

2

31

65

FDA Oncology

@FDAOncology

4 years

Today FDA approved nivolumab + ipilimumab & 2 cycles of platinum-doublet chemotherapy as 1st-line treatment for patients with metastatic/recurrent NSCLC with no EGFR or ALK genomic tumor aberrations. #lcsm nivolumab: ipilimumab:

1

39

63

FDA Oncology

@FDAOncology

6 years

25-year FDA review finds only a small number of oncology products granted accelerated approval fail to verify clinical benefit, while AA brings products to market earlier for patients with life-threatening cancer @JAMAOnc #OCEpub

Accelerated Approvals for Malignant Hematology and Oncology Products

This review describes all malignant hematology and oncology accelerated approvals from inception of the US Food and Drug Administration accelerated approval program.

jamanetwork.com

2

43

58

FDA Oncology

@FDAOncology

2 years

Today, FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer, a newly defined subset of HER2-negative breast cancer. This is the first drug approved to treat this subtype. thread 1/3 #bcsm

5

28

60

FDA Oncology

@FDAOncology

10 months

From Jan 1, 2000, to Oct 31, 2022, FDA granted 573 oncology indication approvals for 206 distinct oncology products. Read more from a review by FDA authors: Trends in the approval of cancer therapies by the FDA in the twenty-first century.

Trends in the approval of cancer therapies by the FDA in the twenty-first century

Nature Reviews Drug Discovery - Cancer therapy has changed substantially since the beginning of the century, with advances including kinase inhibitors and immunotherapies resulting in substantial...

www.nature.com

0

33

60

FDA Oncology

@FDAOncology

5 years

FDA approved Piqray (alpelisib) in combination with fulvestrant for postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated advanced/metastatic breast cancer following progression on/after an endocrine-based regimen

1

27

57

FDA Oncology

@FDAOncology

11 months

We’re in Chicago! FDA Oncology staff attending @ASCO #ASCO23 enjoyed riding the Chicago @Metra 🚇. Come to our talks, come meet us ➡️

2

8

59

FDA Oncology

@FDAOncology

2 years

Feb. 3 is #NationalWomenPhysiciansDay , birthday of Elizabeth Blackwell, the 1st woman to earn a medical degree in the US. We're proud of the many women physician leaders in FDAOncology. A few are pictured here. #WomenInMedicine

0

11

59

FDA Oncology

@FDAOncology

4 years

FDA approved olaparib (LYNPARZA, AstraZeneca) for maintenance treatment of patients w/deleterious or suspected deleterious gBRCAm metastatic #pancreatic adenocarcinoma that hasn't progressed on at least 16 wks of 1st-line platinum-based chemo regimen

1

46

60

FDA Oncology

@FDAOncology

3 years

#FDAODAC votes 7 to 2 in favor of maintaining the indication for atezolizumab in combination w/nab-paclitaxel for patients with unresectable locally advanced or metastatic TNBC whose tumors are PD-L1+ while additional trial(s) are completed.

10

23

57

FDA Oncology

@FDAOncology

4 years

Today FDA approved brigatinib (ALUNBRIG, ARIAD Pharmaceuticals) for ALK-positive metastatic non-small cell lung cancer and the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular) as a companion diagnostic for brigatinib. #lcsm

2

26

53

FDA Oncology

@FDAOncology

2 years

Read about FDA approvals from 2010-2020 for the treatment of breast malignancies and their relevant clinical trials, endpoints, and regulatory considerations - via @CCR_AACR . Important article by our breast cancer team in Division of Oncology 1! #bcsm

0

32

56

FDA Oncology

@FDAOncology

4 years

Today we were excited to hear Dr Bruce Chabner from @MGHCancerCenter & @OncJournal and formerly @theNCI discuss his career in pharmacology, medical oncology and drug development for our first "Icons in Oncology" lecture series for FDA staff @drjennifergao @realrickpazdur

1

11

57

FDA Oncology

@FDAOncology

3 years

FDA approved pembrolizumab + chemo for high-risk early-stage triple-negative breast cancer (TNBC) and granted regular approval (was accelerated in 2020) for locally recurrent unresectable/metastatic TNBC expressing PD-L1 #bcsm #OCENewsBurst

4

26

54

FDA Oncology

@FDAOncology

3 months

FDA approved osimertinib with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. #OCENewsBurst

FDA approves osimertinib

FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer

www.fda.gov

0

30

56

FDA Oncology

@FDAOncology

2 years

We welcomed 112 hematology/oncology fellows from across the U.S. to the Nov 2021 #FDA_ASCOFellowsDay Workshop for a day of #regulatory science. #OncTwitter cc @ASCO . Learn more about our oncology #MedEd programs via OCE's #ProjectSocrates :

1

12

55

FDA Oncology

@FDAOncology

6 years

2017 a banner year for FDA approvals in hematologic malignancies. In this graphic, purple=4 new drug approvals for AML; red=5 new drugs for ALL/NHL; orange=supplemental approvals for new indications #ASH17

0

42

52

FDA Oncology

@FDAOncology

4 years

Just published online: #FDAOncology 's initial experience with the Real-Time Oncology Review Program. @CCR_AACR @realrickpazdur @DrJuliaBeaver @pkluetz @drjennifergao #RealTimeOncReview #RTOR

0

25

52

FDA Oncology

@FDAOncology

5 years

It was 20 years ago almost today that @realrickpazdur came to the FDA. He's always in and never out of style and he's guaranteed to raise a smile. And he seems to have enjoyed our selfie line! Want to join us? #FDAOncology is hiring!

3

8

54

FDA Oncology

@FDAOncology

2 years

FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 (ERBB2) mutations. #lcsm

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer

www.fda.gov

1

21

54

FDA Oncology

@FDAOncology

3 years

FDA approved pralsetinib (GAVRETO, Blueprint Medicines) for advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory

FDA approves pralsetinib for RET-altered thyroid cancers

Hematology / Oncology News Burst

www.fda.gov

0

13

52

FDA Oncology

@FDAOncology

7 years

Kymriah approved for patients age 25 and under with relapsed/refractory acute lymphoblastic #leukemia #leusm

U.S. FDA

@US_FDA

7 years

FDA approves first gene therapy available in US, ushering in new approach to treatment of cancer & other diseases

8

241

217

1

48

50

FDA Oncology

@FDAOncology

5 years

FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor - #NTRK gene fusion

0

26

53

FDA Oncology

@FDAOncology

13 days

FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. #OCENewsBurst

FDA approves nogapendekin alfa inbakicept-pmln for bladder cancer

On April 22, 2024, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) for non-muscle invasive bladder cancer.

www.fda.gov

1

26

53

FDA Oncology

@FDAOncology

1 year

FDA approved elacestrant (Orserdu) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. #OCENewsBrief #bcsm

FDA approves elacestrant for ER-positive

FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

www.fda.gov

2

17

51

FDA Oncology

@FDAOncology

20 days

"Asha" means hope. FDA Oncology's Project Asha aims to increase oncology clinical trial access in India. India accounts for ~20% of the global population yet only 1.5% of global trials are conducted there. Lead: @GsrivastavaMD #OCEProjectAsha

Project Asha

Collaboration to increase cancer clinical trial access in India

www.fda.gov

2

15

54

FDA Oncology

@FDAOncology

5 years

Dr Sharpless of ⁦ @theNCI ⁩ and soon acting FDA Commissioner notes large number of #FDAOncology approvals in 2018 for treatment of cancer. Exciting time in cancer research & drug development! #AACR19

2

20

51

FDA Oncology

@FDAOncology

4 years

FDA grants accelerated approval to capmatinib (TABRECTA, Novartis) for metastatic #NSCLC with MET exon 14 skipping. FDA also approved the FoundationOne CDx assay as a companion diagnostic for capmatinib. #LCSM

1

25

50

FDA Oncology

@FDAOncology

1 month

FDA Oncologic Drugs Advisory Committee to meet April 12 to discuss the use of minimal residual disease as an endpoint in multiple myeloma clinical trials to support accelerated approval of a new product or a new indication. #FDAODAC

Meeting of the Oncologic Drugs Advisory Committee

April 12, 2024 Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

www.fda.gov

2

16

51

FDA Oncology

@FDAOncology

6 years

2017 was a banner year for FDA approvals in hematologic malignancies. In this graphic, purple lines=4 new drug approvals for AML; red=5 new drugs for ALL/NHL; orange=supplemental approvals for new indications

1

42

49

FDA Oncology

@FDAOncology

6 years

FDA granted accelerated approval to lorlatinib for ALK-pos metastatic NSCLC that progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or progressed on alectinib or ceritinib as the first ALK inhibitor for metastatic disease

1

26

49

FDA Oncology

@FDAOncology

3 years

Read more about today's FDA accelerated approval of sotorasib (Lumakras) for patients with KRAS G12C‑mutated locally advanced or metastatic NSCLC who have received at least 1 prior systemic therapy. Drug label 👉 #OCENewsBurst 👇

0

27

47

FDA Oncology

@FDAOncology

6 years

FDA granted accelerated approval to pembrolizumab for adult & pediatric patients with refractory primary mediastinal large B-cell #lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy #lymsm

0

30

49

FDA Oncology

@FDAOncology

5 months

FDA approved nirogacestat (OGSIVEO, SpringWorks Therapeutics) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors. #OCENewsBurst

0

20

49

FDA Oncology

@FDAOncology

6 years

#FDAOncology Perspective: Metastasis-free Survival—A New End Point in Prostate Cancer Trials @NEJM @pkluetz @realrickpazdur #prostatecancer #pcsm #OCEpubs

0

31

49

FDA Oncology

@FDAOncology

5 years

FDA approved olaparib (LYNPARZA, AstraZeneca) for maintenance treatment of patients w/BRCA-mutated (gBRCAm or sBRCAm) advanced ovarian, fallopian tube or primary peritoneal cancer in complete or partial response to 1st-line platinum-based chemotherapy

0

33

46

FDA Oncology

@FDAOncology

4 years

Today we talked w/Black patients & providers about inclusion in clinical trials & cancer health equity. @VCUMassey Dr Robert Winn, @DukeMedSchool Dr Nadine Barrett, @MelDMann ; @ASCOPres Dr Lori Pierce, @HowardU Dr Lori Wilson. @rea_blakey @realrickpazdur @LolaFashoyinAje

2

13

48

FDA Oncology

@FDAOncology

3 years

FDA granted accelerated approval to tepotinib (Tepmetko, EMD Serono) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations

0

21

46

FDA Oncology

@FDAOncology

5 years

Why does this Canada geese family like the FDA campus in Silver Spring, MD? Who wouldn't? FDA offers onsite daycare, flexible schedules & work with talented multidisciplinary teams. We're hiring #oncologists and heme malignancy experts. Give us a honk: FDAOncology @fda .hhs.gov

3

8

46

FDA Oncology

@FDAOncology

3 years

FDA approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens

0

21

45

FDA Oncology

@FDAOncology

1 year

FDA granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics) for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer after at least 1 prior systemic therapy. FDA also approved two companion diagnostics for Krazati.

FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSC

FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC

www.fda.gov

0

23

46

FDA Oncology

@FDAOncology

2 years

Today, oncology reviewers and staff who joined the FDA in the past 3 years met on the White Oak campus to have pizza with OCE Director @realrickpazdur , OCE leadership and staff, and Divisional leadership. Bonus visit from @DrCaliff_FDA !

2

5

44

FDA Oncology

@FDAOncology

4 years

FDA approved neratinib (NERLYNX, Puma Biotechnology) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting #BCSM

1

24

46

FDA Oncology

@FDAOncology

4 years

On Dec 16, 2019, FDA approved enzalutamide (XTANDI®, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC). FDA previously approved enzalutamide for patients with castration-resistant prostate cancer. #pcsm

2

34

45

FDA Oncology

@FDAOncology

2 years

Welcome to the 20 #OncTwitter fellows selected for the 2022-2023 @FDAOncology - @AACR Oncology Educational Fellowship, now in its 3rd year! Excited to have you and to kick off another great year! @drjennifergao @realrickpazdur #OCEProjectSocrates #regulatory #MedEd

4

8

47

FDA Oncology

@FDAOncology

5 years

Today, the FDA Oncology Center of Excellence began #ProjectFacilitate , a pilot program to serve as a single point of contact for physicians to submit #ExpandedAccess requests for patients with cancer.

2

43

46

FDA Oncology

@FDAOncology

4 years

Meet Dr. Julia Beaver @DrJuliaBeaver , recently appointed Chief of Medical Oncology for the Oncology Center of Excellence. She continues to support the cancer community curing COVID-19. #OCEWorks4U

2

3

45

FDA Oncology

@FDAOncology

3 years

FDA grants accelerated approval to pembrolizumab (Keytruda, Merck) in combination w/trastuzumab, fluoropyrimidine & platinum chemo for 1st-line treatment of patients w/locally advanced unresectable/metastatic HER2+ gastric/GEJ adenocarcinoma #OCENewsBurst

2

22

47

FDA Oncology

@FDAOncology

2 years

He grew up fast living above a bar in Calumet City. He worked washing dishes after his father went blind. His dream: to become a doctor who teaches doctors. Hear @realrickpazdur on his early years, in this @ASCO podcast with @dhjutsw1 & #PatLoehrer #MedEd

3

11

46

FDA Oncology

@FDAOncology

4 years

May 19: FDA approved olaparib (LYNPARZA, AstraZeneca) for deleterious/suspected deleterious germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer that has progressed following treatment with enzalutamide or abiraterone #pcsm

1

22

43

FDA Oncology

@FDAOncology

2 years

#FDAOncology perspective: The On- and Off-Ramps of Oncology Accelerated Approval - via @NEJM by @LolaFashoyinAje @GautamMehtaMD @DrJuliaBeaver @realrickpazdur

The On- and Off-Ramps of Oncology Accelerated Approval | NEJM

To address ongoing concerns about the implementation of the FDA’s Accelerated Approval pathway in oncology, a comprehensive strategy is needed — one that equally emphasizes “on-ramp” and “off-ramp”...

www.nejm.org

0

20

45

FDA Oncology

@FDAOncology

7 years

#ODAC votes 10-0 in favor of tisagenlecleucel for patients age 3-25 yrs w/ relapsed/refractory B-cell acute lymphoblastic #leukemia #leusm

3

46

43

FDA Oncology

@FDAOncology

3 years

The Drug-Dosing Conundrum in Oncology—When Less Is More. Drs. Mirat Shah, Atiqur Rahman, Marc Theoret & @realrickpazdur - via @NEJM

The Drug-Dosing Conundrum in Oncology — When Less Is More | NEJM

Doses and schedules of oncology drugs are sometimes inadequately characterized before registration trials. The “more is better” paradigm is still used for dose selection, despite the recognition th...

www.nejm.org

1

10

43

FDA Oncology

@FDAOncology

7 months

FDA Oncologic Drugs Advisory Committee voted 10-2 against the question: Can the primary endpoint, PFS per blinded independent central review, be reliably interpreted in CodeBreaK200? Re: sotorasib for KRAS G12C mutated advanced/metastatic NSCLC. #FDAODAC

Oncologic Drugs Advisory Committee Meeting

The committee will discuss supplemental new drug application (sNDA) 214665/s-005, for LUMAKRAS (sotorasib) tablets, submitted by Amgen Inc., for the proposed...

www.youtube.com

1

15

43

FDA Oncology

@FDAOncology

4 years

Congratulations to OCE Director Dr. Richard Pazdur for receiving the Simon M. Shubitz Cancer Prize and Lectureship today from the University of Chicago.

UChicagoCancerCenter

@UCCancerCenter

4 years

Today, we are pleased to host Dr. Richard Pazdur, director for the U.S. @FDAOncology Center of Excellence. As this year's awardee of the Simon M. Shubitz Cancer Prize and Lectureship, he is discussing the beliefs and realities of cancer drug development from 1980 to 2020.

1

3

18

0

8

44

FDA Oncology

@FDAOncology

5 months

FDA Oncology's @timilpatel has been invited to speak at the President’s Cancer Panel @PresCancerPanel on December 7 to discuss gaps and opportunities related to the use of technology to support cancer patient navigation. Learn more ⤵️ .

11

5

44

FDA Oncology

@FDAOncology

11 days

Bring Your Child to Work Day! FDA Oncology's @drjennifergao and sons enjoyed getting photos with @realrickpazdur and " @DrCaliff_FDA ," and took part in other activities around the campus. #BYCTWD

1

6

49

FDA Oncology

@FDAOncology

5 years

FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy #lcsm

0

23

43

FDA Oncology

@FDAOncology

6 years

Biosimilar Drugs for Cancer Emerge #FDAOncology @theNCI

Biosimilar Drugs for Cancer Emerge

As the patents on widely used biological drugs to treat cancer expire, biosimilar drugs are being developed for the treatment of patients with cancer. You can learn how biosimilars may expand...

www.cancer.gov

0

27

43

FDA Oncology

@FDAOncology

5 years

FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma

1

23

42

FDA Oncology

@FDAOncology

6 years

FDA review finds most oncology products granted accelerated approval have clinical benefit verified a few years later. Patients with life-threatening cancer get earlier access to treatment

Accelerated Approvals for Malignant Hematology and Oncology Products

This review describes all malignant hematology and oncology accelerated approvals from inception of the US Food and Drug Administration accelerated approval program.

jamanetwork.com

3

40

FDA Oncology

@FDAOncology

5 years

FDA approved gilteritinib (XOSPATA, Astellas Pharma US Inc.) for treatment of adults with relapsed or refractory acute myeloid leukemia ( #AML ) with a FLT3 mutation. FDA also approved a companion diagnostic, LeukoStrat CDx FLT3 Mutation Assay #leusm

0

21

41