Pharmaceutical Business News

Merck KGaA and Pfizer’s Avelumab fails in trial

(Marketwatch) Merck KGaA and Pfizer Inc. said on Thursday that avelumab, a cancer immunotherapy, failed to meet the primary objective of a phase 3 trial in patients with a type of lung cancer. The trial didn't meet the endpoint of improving overall survival in patients whose tumors are PD-L1 positive, the companies said. The Javelin Lung 200 trial compared avelumab to docetaxel, a chemotherapy drug, in patients with advanced non-small-cell
Cancer Discovery Immunotherapies

FDA Approves the Roll-Over Combination Study with Checkpoint Inhibitor Immunotherapies to Allow Continued Access to BriaVax™ in Patients with Advanced Breast Cancer

The FDA has approved the roll-over combination study of the investigational breast cancer vaccine, BriaVax™ with pembrolizumab {Keytruda; manufactured by Merck & Co., Inc. or ipilimumab {Yervoy; manufactured by Bristol-Myers Squibb Company for patients previously treated with BriaVax™ from the ongoing Phase I/IIa Clinical Trial in Advanced Breast Cancer. BriaVax™ is a whole-cell breast cancer vaccine genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune
cancer Cancer Discovery

Novartis garners first ever FDA approval for a CAR-T cell therapy, Kymriah(TM), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice

Novartis announced today that the US Food and Drug Administration (FDA) has approved Kymriah(TM)(tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's
Biotechnology cancer Clinical Trials Immunotherapies

FDA Halts Three Multiple Myeloma Studies Evaluating Merck’s KEYTRUDA®

Merck known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in the blood cancer multiple myeloma. This decision follows a review of data by the Data Monitoring Committee in which more deaths were observed in the KEYTRUDA arms of KEYNOTE-183
cancer Immunotherapies

Photo-Bombing Cancer

When Kerstin Stenson, MD, describes the innovative technique she is helping develop to fight cancer, it seems like she’s describing a Tom Clancy military espionage novel. Stenson is treating patients with photoimmunotherapy, PIT for short, an experimental technique that combines the immune system’s ability to target cancer cells precisely with laser energy’s ability to destroy those cells. Like a high-tech weapon in a Clancy thriller, PIT delivers extremely precise, lethal