State and National Legislative & Regulatory Issues
ASCO Research Statement Recommends Cancer Clinical Trials Provide A Way To Assess Ovarian Toxicity
Healio (10/3, Shinkle) reports, “ASCO released a research statement outlining new recommendations regarding the appropriate assessment of ovarian toxicity in cancer clinical trials.” The new “statement’s three key recommendations aim to provide researchers with a way to measure ovarian toxicity in cancer clinical trials while also encouraging data acquisition.” According to Healio, “The goal is to provide patients and clinicians with information regarding potential long-term effects of certain treatments.” The statement was published in The Lancet Oncology.
Learn More
FDA Approvals
On October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
Learn More
On October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted accelerated approval to entrectinib for pediatric patients 12 years of age and older for this indication.
FDA also approved a new oral pellet formulation for entrectinib, and the prescribing information now includes instructions for making an oral suspension from the capsules.
Learn More
On October 27, 2023, the Food and Drug Administration approved toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
Learn More
