FDA Approvals, News & Updates
Osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) has received another new indication,... Read More ›
Officials with the FDA have approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone for adults... Read More ›
Amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed has been green-lighted by the FDA for adult patients... Read More ›
On September 17, 2024, FDA officials approved pembrolizumab (Keytruda, Merck)... Read More ›
Officials with the FDA approved durvalumab (Imfinzi; AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known EGFR mutations or anaplastic lymphoma kinase rearrangements. Read More ›
On August 14, 2024, the FDA approved axatilimab-csfr (Niktimvo; Incyte Corporation), a colony-stimulating factor-1 receptor–blocking antibody, for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least 2 prior lines of systemic therapy. Read More ›
Officials with the FDA approved lazertinib (Lazcluze; Janssen Biotech, Inc) in combination with amivantamab-vmjw (Rybrevant; Janssen Biotech, Inc) for the first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. Read More ›
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 ›