Takeda's Alunbrig wins lung cancer approval; Atara offers another positive MS drug update
→ Takeda’s tyrosine kinase inhibitor brigatinib (branded Alunbrig) — a drug the Japanese drugmaker acquired with its $5.2 billion Ariad buyout — has secured approval for a subset of lung cancer patients. Last November, the company put out late-stage data comparing brigatinib against crizotinib in 275 advanced non-small-cell-lung-cancer patients who tested positive for the ALK gene. Data showed the Takeda drug helped patients by a median 24 months without their cancer spreading, hitting the primary endpoint, versus 11 months in the crizotinib group. The only problem? Crizotinib, the control in the trial, was the first-ever ALK inhibitor approved, but since then, companies like Pfizer, Novartis and Roche have all come up with their own.
→ Atara Biotherapeutics has a new update on a Phase I study to bolster its case for targeting EBV-infected B cells in the treatment of progressive multiple sclerosis. The South San Francisco-based biotech said ATA188, its allogeneic T cell therapy, continued to be well-tolerated at 12 months and to help patients improve on a disability scale. Atara has now resumed enrollment into the second, placebo-controlled portion of the study after a brief Covid-19 pause, where they will monitor additional measurements of disease control and reversal.
→ A New York biotech, which recently went public this year, has the FDA stamp of encouragement in the form of fast track status for its experimental lipid substrate replacement therapy that is being developed for use in patients with intestinal failure-associated liver disease. The therapy from Protara Therapeutics generated a statistically significant improvement in cholestasis — reduction or stoppage of bile flow — in a recent mid-stage study.