The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
Dr Christopher Cannon on Dual SGLT1/2 Inhibitors
May 27th 2023Christopher P. Cannon, MD, a professor of medicine at Harvard Medical School and senior physician in the Cardiovascular Division at Brigham and Women’s Hospital, spoke about the benefit seen in a study of sotagliflozin for patients with acute heart failure.
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FDA Expands Dapagliflozin Label to Include Reducing Risk of CV Death in Heart Failure
May 9th 2023Just over a year since AstraZeneca announced topline results, the FDA has approved a label expansion to include reducing cardiovascular (CV) death and heart failure–related hospitalizations for dapagliflozin (Farxiga) based on results of the phase 3 DELIVER trial.
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Pembrolizumab Receives Full Approval for Select Patients With MSI-H or dMMR Solid Tumors
March 29th 2023The FDA has granted full approval to pembrolizumab for the treatment of some patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed following previous treatment.
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FDA Expands Abemaciclib Indication in HR+/HER2–, Node+, High-Risk Breast Cancer
March 7th 2023The FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence.
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FDA Approves Efanesoctocog Alfa for Hemophilia A
February 24th 2023Efanesoctocog alfa is the first factor VIII therapy to overcome the interaction with endogenous von Willebrand factor, which creates a ceiling of 8 to 19 hours on the half-life of current factor VIII replacement products, which in turn creates the need for more frequent dosing.
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FDA Approves Sacituzumab Govitecan for Pre-Treated HR+/HER2- Metastatic Breast Cancer
February 3rd 2023The approval is based on results from the phase 3 TROPiCS-02 trial demonstrating overall and progression survival benefits with sacituzumab govitecan compared with physician’s choice of single-agent chemotherapy.
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FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
January 28th 2023The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a previous Bruton tyrosine kinase (BTK) inhibitor.
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FDA Approves Elacestrant for ER+/HER2–, ESR1-Mutated Advanced or Metastatic Breast Cancer
January 27th 2023The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.
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Tucatinib Plus Trastuzumab Approved for RAS Wild-type, HER2+ Unresectable or Metastatic CRC
January 19th 2023The combination of tucatinib and trastuzumab received accelerated approval from the FDA to treat adults with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer (mCRC) that advances after treatment with specific types of chemotherapy.
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FDA’s Lecanemab Approval Will Raise Pricing, Access Challenges, Says Dr Alvaro Pascual-Leone
January 6th 2023The FDA’s approval of lecanemab for Alzheimer disease is very important, but there will remain significant challenges around pricing and access that will need to be addressed to deliver on the promise the therapy actually represents, said Alvaro Pascual-Leone, MD, PhD, of Harvard Medical School.
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