FLASCO News

Boehringer Ingelheim Pharmaceuticals, Inc.

Beamion LUNG-1 study results for zongertinib in treatment-naïve patients with HER2-mutant advanced NSCLC published in The New England Journal of Medicine

Posted May 19, 2026

Ridgefield, Conn. and Ingelheim, Germany. April 16, 2026 — Boehringer Ingelheim today announced that The New England Journal of Medicine (NEJM) published results from the Phase 1b Beamion LUNG-1 trial of HERNEXEOS® (zongertinib tablets) in treatment-naïve patients with advanced non-small cell lung cancer (NSCLC) who have HER2 activating mutations in the tyrosine kinase domain (TKD). The data in the manuscript,... Read More »

FDA

FDA Approves Relacorilant With Nab-Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Posted March 26, 2026

On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.... Read More »

FDA

FDA Approves Nivolumab With Chemotherapy for Previously Untreated Hodgkin Lymphoma

Posted March 26, 2026

On March 20, 2026, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). The FDA also granted traditional approval to nivolumab for the following indications in... Read More »

FDA

FDA Approves Teclistamab in Combination With Daratumumab Hyaluronidase-Fihj for Relapsed or Refractory Multiple Myeloma

Posted March 6, 2026

On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.  Read More Read More »

FDA

FDA Grants Accelerated Approval to Zongertinib for Unresectable or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Posted March 5, 2026

On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.... Read More »

FDA Grants Traditional Approval to Encorafenib for Metastatic Colorectal Cancer With a BRAF V600E Mutation

Posted February 26, 2026

On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated... Read More »

FDA

FDA Approves Pembrolizumab With Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Posted February 10, 2026

On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test,... Read More »

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