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The European Commission approves label expansion of Pfizer's (PFE) Lorviqua as a first-line treatment for ALK-positive non-small cell lung cancer. ....
Pfizer’s ALK inhibitor Lorbrena scores expanded FDA approval for first-line NSCLC The European Medicines Agency is also reviewing an application for the drug The US Food and Drug Administration (FDA) has approved a new indication for Pfizer’s Lorbrena in the first-line treatment of metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The expanded approval is based on the phase 3 CROWN trial, which demonstrated that Lorbrena (lorlatinib) reduced the risk of disease progression or death by 72% in metastatic ALK-positive NSCLC patients compared to Xalkori (crizotinib). In addition, Lorbrena also showed benefit in patients with central nervous system involvement. There were 17 patients in the Lorbrena arm and 13 in the Xalkori arm with measurable brain metastases based on baseline imaging. ....
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. ....