FDA Grants Priority Review to Frontline Pembro to Treat Recurrent, Metastatic HNSCC
February 11th 2019The FDA granted a priority review to the supplemental biologics license application for pembrolizumab (Keytruda) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
FDA Expands Pemetrexed Approval for Frontline Pembrolizumab/Chemo Combo in NSCLC
January 31st 2019The FDA has expanded the indication for pemetrexed (Alimta) injection in combination with pembrolizumab (Keytruda) and platinum-based chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) without EGFR or ALK alterations.
Pembrolizumab Shows OS Benefit in PD-L1+ Esophageal Cancer
January 26th 2019Pembrolizumab (Keytruda) was found to reduce the risk of death by 31% in patients with PD-L1–positive (combined positive score [CPS] ≥10) advanced or metastatic esophageal or esophageal junction carcinoma who progressed on standard therapy, according to phase III findings of the KEYNOTE-181 trial.
Dabrafenib/Trametinib Combo Induces High Responses in BRAF V600E-Mutant Biliary Tract Cancer
January 24th 2019The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) induced responses in nearly half of patients with BRAF V600E–mutated biliary tract cancer (BTC) who participated in a phase II basket trial that enrolled patients with BRAF V600E–mutated rare cancers.
Pembrolizumab/Trastuzumab Induction Highly Active in HER2+ Gastric, GEJ Cancer
January 24th 2019Two-thirds of patients with untreated metastatic HER2-positive esophagogastric adenocarcinoma remained free of disease progression at 6 months with a combination of pembrolizumab (Keytruda), trastuzumab (Herceptin), and chemotherapy, a small clinical trial showed.
FDA Grants Umbralisib Breakthrough Designation for Marginal Zone Lymphoma
January 23rd 2019The FDA has granted umbralisib (TGR-1202) a breakthrough therapy designation for the treatment of adult patients with marginal zone lymphoma (MZL) who have received 1 prior anti-CD20 regimen, according to TG Therapeutics, Inc., the developer of the PI3K-delta inhibitor.
FDA Approves Third Trastuzumab Biosimilar
January 21st 2019The FDA has granted an approval to SB3 (Ontruzant; trastuzumab-dttb), a trastuzumab (Herceptin) biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.