Showing posts from June, 2021

Novartis announces positive data from phase II ELARA trial of Kymriah in patients with relapsed or refractory follicular lymphoma

  Novartis announced robust data from the primary analysis of the pivotal phase II ELARA trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL). Data will be presented as an oral presentation during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting (Abstract #7508; oral presentation: Monday, June 7, 10:30 AM CDT). “Patients with follicular lymphoma who do not respond to their current treatment or who relapse early after treatment often have to endure multiple treatments, which can result in diminished clinical outcomes with each successive therapy,” said Stephen J. Schuster, MD, the Robert and Margarita Louis-Dreyfus Professor in Chronic Lymphocytic Leukemia and Lymphoma Clinical Care and Research in Penn’s Perelman School of Medicine and director of the Lymphoma Program at the Abramson Cancer Center. Schuster will present the results at ASCO. “Our goal as researchers is to continue to explore the

Bristol Myers Squibb gets European approval for Opdivo plus Yervoy to treat unresectable malignant pleural mesothelioma

  Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM). The EC’s decision is based on results from the CheckMate -743 trial, the first and only positive phase 3 study of an immunotherapy in first-line MPM. The trial met its primary endpoint, showing superior overall survival (OS) with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomized patients. “After many years of limited progress in the treatment of malignant mesothelioma, we saw an important clinical benefit for patients with nivolumab plus ipilimumab in the CheckMate -743 trial,” said Paul Baas, M.D., Ph.D., Department of Thoracic Oncology, Netherlands Cancer Institute and the University of Leiden. “With the European Commission approval of this dual immunotherapy combination, patients and doctors will now have a new treatmen

Zydus Cadila gets tentative USFDA nod to market lung cancer treatment drug

Drug firm Zydus Cadila on Thursday said it has received tentative approval from the US health regulator to market Osimertinib tablets , used to treat lung cancer . The company has received tentative approval from the US Food and Drug Administration ( USFDA ) to market Osimertinib tablets in the strengths of 40 mg and 80 mg, Zydus Cadila, part of the Cadila Healthcare group, said in a regulatory filing. Osimertinib is used to treat lung cancer. Osimertinib works by slowing or stopping the growth of cancer cells. The company said the newly approved medication will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 318 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in the financial year 2003-04. Source: