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FDA Oncology
@FDAOncology
FDA Oncology Center of Excellence expedites medical product development to improve the lives of people with cancer.
Silver Spring, MD
fda.gov/OCE
Joined February 2017
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  • user avatar
    FDA Oncology
    @FDAOncology
    Dec 3, 2018
    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
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    FDA Oncology
    @FDAOncology
    Apr 19, 2019
    Today, FDA approved pembrolizumab plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma go.usa.gov/xmWx6
  • user avatar
    FDA Oncology
    @FDAOncology
    Jan 8, 2020
    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 go.usa.gov/xpJBH
  • user avatar
    FDA Oncology
    @FDAOncology
    Dec 12, 2017
    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
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    FDA Oncology
    @FDAOncology
    Apr 28, 2020
    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 go.usa.gov/xvmYW
  • user avatar
    FDA Oncology
    @FDAOncology
    Nov 26, 2018
    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: go.usa.gov/xP63e
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    FDA Oncology
    @FDAOncology
    Dec 18, 2020
    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 go.usa.gov/xA42x
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    FDA Oncology
    @FDAOncology
    Jul 10, 2020
    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. fda.gov/drugs/guidance…
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    FDA Oncology
    @FDAOncology
    Jun 15, 2020
    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: accessdata.fda.gov/drugsatfda_doc…
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    FDA Oncology
    @FDAOncology
    Mar 8, 2019
    FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative #breastcancer. #bcsm Drug label: go.usa.gov/xEGzx
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    FDA Oncology
    @FDAOncology
    May 15, 2020
    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.) go.usa.gov/xvebs
  • user avatar
    FDA Oncology
    @FDAOncology
    Aug 30, 2023
    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
    From fda.gov
    37K
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    FDA Oncology
    @FDAOncology
    Feb 2, 2022
    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 bit.ly/3L25rKx
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    FDA Oncology
    @FDAOncology
    Oct 25, 2022
    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. fda.gov/drugs/resource… #OCENewsBurst