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FDA and NCCN Guideline Updates for September 2024
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy based on the LIBRETTO-531 trial. Read More
On September 25, 2024, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test based on the LAURA trial. Read More
On September 20, 2024, the FDA approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT) based on the IMROZ trial. Read More
On September 19, 2024, the FDA approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor based on the MARIPOSA-2 trial. Read More
On September 17, 2024, the FDA approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM) based on KEYNOTE-483. Read More
Also on September 17, 2024, the FDA approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor for the adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. Additionally, the FDA also approved the ribociclib and letrozole co-pack (Kisqali Femara Co-Pack, Novartis Pharmaceuticals Corporation) for the same indication. Approval was based on the NATALEE trial. Read More
On September 12, 2024, the FDA approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS) based on the IMscin001 trial. Read More
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