FDA Approvals, News & Updates
On August 2, 2024, the FDA granted accelerated approval to afamitresgene autoleucel (Tecelra; Adaptimmune, LLC), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or -cleared companion diagnostic devices. Read More ›
The Centers for Medicare & Medicaid Services now covers the test based on the criteria established in its National Coverage Determination for blood-based CRC screening tests (NCD 210.3). The test is covered
once every 3 years for eligible Medicare beneficiaries. Read More ›
On June 26, 2024, the FDA approved epcoritamab-bysp (Epkinly; Abbvie and Genmab) as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after ≥2 lines of prior therapy. Read More ›
On November 22, 2023, the FDA approved efbemalenograstim alfa-vuxw (Ryzneuta; Evive Biotech) subcutaneous injection, a novel long-acting granulocyte colony-stimulating factor (G-CSF), for the prevention and treatment of febrile neutropenia in adults with nonmyeloid malignancies who are receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia. Read More ›
On November 16, 2023, the FDA approved capivasertib (Truqap; AstraZeneca Pharmaceuticals), in combination with fulvestrant, for the treatment of hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer in patients with ≥1 PIK3CA, AKT1, or PTEN genetic mutations, as detected by an FDA-approved test. Read More ›
On November 15, 2023, the FDA approved repotrectinib (Augtyro; Bristol Myers Squibb), a ROS1 tyrosine kinase inhibitor (TKI), for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) associated with ROS1 fusion. Read More ›
On November 16, 2023, the FDA approved a supplemental new drug application for enzalutamide (Xtandi; Astellas Pharma and Pfizer), an androgen receptor signaling inhibitor, for the treatment of nonmetastatic, castration-sensitive prostate cancer with biochemical recurrence (BCR) at high risk for metastasis (high-risk BCR). Read More ›
On November 9, 2023, the FDA approved Flowflex COVID-19 Antigen Home Test (Flowflex; ACON Laboratories), the first over-the-counter (OTC) antigen test for COVID-19 for use by individuals aged ≥14 years. Read More ›
On November 27, 2023, the FDA approved nirogacestat (Ogsiveo; SpringWorks Therapeutics) for adults with progressing desmoid tumors who require systemic treatment. Read More ›