U S FDA Expands Approval of Pfizer s LORBRENA as First-Line Treatment for ALK-Positive Metastatic Lung Cancer wallstreet-online.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from wallstreet-online.de Daily Mail and Mail on Sunday newspapers.
Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or death for treatment with LORBRENA vs. XALKORI ® The U.S. Food and Drug Administration approved Pfizer Inc.’s supplemental New Drug Application for LORBRENA ® expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase -positive non-small cell lung cancer . LORBRENA is now indicated for … Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or death for treatment with LORBRENA vs. XALKORI ® The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for LORBRENA
In a report published Monday, Morgan Stanley analyst David Risinger and his team reiterated an Overweight rating on Bristol-Myers Squibb Co (NYSE: BMY) after the National Comprehensive Cancer Network (NCCN) updated its guidelines for the treatment of Non-Small Cell Lung Cancer (NSCLC) to. Read More. Don t Miss Any Updates! News Directly in Your Inbox Subscribe to:
Mar 4, 2021 10:54am
The FDA has expanded Pfizer s Lorbrena approval to include front-line ALK-positive non-small cell lung cancer.
Pfizer’s Lorbrena has finally broken into front-line non-small cell lung cancer, where Novartis, Roche and Takeda are already jockeying for a niche market.
The FDA expanded Lorbrena’s use into newly diagnosed patients with ALK-positive NSCLC, Pfizer said Wednesday. With that front-line nod, the agency converted Lorbrena s conditional green light for previously treated cases into a full approval.
How does Pfizer expect to compete in such a crowded field? As a third-generation ALK inhibitor, Lorbrena has arguably the best efficacy data in head-to-head tests against its predecessor, Xalkori.
Sun Pharma Advanced Research Company (SPARC) skids 2.21% to Rs 170 after the company said that the US drug regulator has ruled against its appeal related to Taclantis, its under-development product for the treatment of breast cancer.The Office of New Drugs (OND) of the U.S. Food and Drug Administration (USFDA) has denied the company s appeal of the Complete Response Letter in relation to the New Drug Application (NDA) for Taclantis.
Taclantis is a novel formulation of paclitaxel developed with SPARC s proprietary Nanotecton technology. Paclitaxel is one of the most widely used cytotoxic agent and is approved for the treatment of breast cancer, ovarian cancer, non small cell lung cancer and pancreatic cancer.