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.
Nivolumab Extends Survival in Advanced or Recurrent Esophageal Cancer
January 18th 2019Nivolumab (Opdivo) significantly improved overall survival (OS) versus chemotherapy in patients with unresectable advanced or recurrent esophageal cancer that is refractory to or intolerant of fluoropyrimidine plus platinum-based therapy, according to topline findings of the phase III ATTRACTION-3 study.
FDA Accepts sBLA for Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel in Nonsquamous NSCLC
January 17th 2019The FDA has accepted a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq), carboplatin, and nab-paclitaxel (Abraxane) as a first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC).
US Cancer Death Rate Drops 27% Over 25 Years
January 16th 2019The cancer death rate declined 27% in the United States from 1991 to 2016, as reported by the American Cancer Society in its annual report, in part due to the significant decline in smoking and an increase in advances for early cancer detection and screening.
Atezolizumab Investigated in Squamous Cell Carcinoma of Head and Neck
January 10th 2019An ongoing randomized phase III clinical trial is investigating the safety and efficacy of atezolizumab (Tecentriq) as an adjuvant treatment in patients with high-risk, locally advanced squamous cell carcinoma of the head and neck (SCCHN) after definitive local therapy, compared with placebo.