FDA Approvals, News & Updates
Officials with the FDA have approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib (Ibrance) and fulvestrant (Faslodex) for adults with endocrine-resistant,... Read More ›
Officials with the FDA have approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment,... Read More ›
Selpercatinib (Retevmo, Eli Lilly and Company) is now available for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation,... Read More ›
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 ›