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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 ....
Posted on 8403 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2021. LORBRENA is a third-generation ALK inhibitor specifically developed to inhibit the most common tumor mutations that drive resistance to current medications and to address brain metastases. Up to 40% of people with ALK-positive lung cancer present with brain metastases. ....
Press release content from Business Wire. The AP news staff was not involved in its creation. LORBRENA® (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA December 28, 2020 GMT NEW YORK (BUSINESS WIRE) Dec 28, 2020 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2021. ....