The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.
Takeda Pharmaceutical Co.’s lung cancer drug Alunbrig received the recommendation of a European Union panel, more than a year after winning U.S. regulatory approval.
Takeda Pharmaceutical’s Alunbrig (brigatinib) hit its Phase III primary endpoints of statistically significant improvement in progression-free survival compared to Pfizer’s Xalkori (crizotinib) in a subset of lung cancer patients following the first pre-specified interim analysis.
Roche Holding AG won U.S. approval to market its skin cancer drug Zelboraf for certain patients with Erdheim-Chester Disease, a rare type of blood cancer, and to market its drug Alecensa as a first choice of treatment for a subset of patients with non-small cell lung cancer.
Mid-stage data shows that Pfizer’s lorlatinib could provide benefits to lung cancer patients who exhibit related brain tumors.
Swiss drugmaker Roche’s Alecensa was recommended for approval in Europe as a first-line treatment for mutated lung cancer.
Novartis’ push to win approval for Zykadia as an initial treatment for a type of lung cancer got a lift with a positive recommendation from the EMA’s CHMP.
Roche’s Alecensa kept people with a specific lung cancer alive longer without their disease progressing than Xalkori as it seeks to move in on Pfizer’s share of early treatment of the disease.
The U.S. Food and Drug Administration (FDA) has granted priority review to the Novartis drug Zykadia as a first-line treatment for some lung cancer patients, the Swiss drugmaker said.
Novartis AG said its cancer drug Zykadia was twice as effective as chemotherapy in slowing the progression of a rare form of lung cancer in a late-stage study.