Paris-based Ipsen secured Fast Track designation from the U.S. Food and Drug Administration for Onivyde (irinotecan liposome injection) for study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen.
The U.S. Food and Drug Administration approved Jazz Pharmaceuticals and company partner PharmaMar’s Zepzelca (lurbinectedin) for adults with metastatic small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration accepted Jazz Pharmaceuticals and Spain-based PharmaMar’s New Drug Application for lurbinectedin under Priority Review.
United Therapeutics announced that the company’s Phase II/III DISTINCT trial evaluating Unituxin (dinutuximab) with irinotecan compared to irinotecan or topotecan alone in relapsed or refractory small cell lung cancer failed to meet the primary efficacy endpoint.
Merck & Co. said a phase 3 trial of the cancer drug Keytruda in combination with chemotherapy showed an increase in the amount of time patients lived with small cell lung cancer (SCLC) without it getting worse, but did not extend overall survival.
AbbVie is slashing 178 jobs from the company’s Stemcentrx subsidiary in South San Francisco.
Swiss drugmaker Roche Holding AG’s U.S. unit Genentech Inc. won approval for the immunotherapy Tecentriq for a tough-to-treat type of lung cancer.
AbbVie halted a Phase III trial evaluating rovalpituzumab tesirine as a second-line therapy for advanced small-cell lung cancer after an Independent Data Monitoring Committee called for the stoppage due to shorter overall survival in the Rova-T arm.
The U.S. Food and Drug Administration approved Catalyst Pharmaceuticals Inc.’s drug Firdapse to treat a rare autoimmune disease.
The Food and Drug Administration approved Bristol-Myers Squibb’s Opdivo for patients whose lung cancer had progressed even after undergoing chemotherapy and at least one other therapy.