The United States Food and Drugs Administration granted a priority review for Roche’s Tecentriq treatment for people suffering with early, non-small-cell lung cancer, the Swiss company said on Aug. 3.
The U.S. Food and Drug Administration granted accelerated approval of Janssen’s Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Takeda’s non-small cell lung cancer (NSCLC) treatment Mobocertinib (TAK-788) is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.
Regeneron and Sanofi’s checkpoint inhibitor Libtayo (cemiplimab-rwlc) won U.S. Food and Drug Administration approval for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression.
AstraZeneca Plc’s cancer drug Imfinzi was approved in Europe and Britain for a spaced-out regimen in a common type of lung cancer to help reduce the frequency of hospital visits while continuing treatment.
Roche’s novel cancer immunotherapy tiragolumab was granted breakthrough therapy designation by the U.S. Food and Drug Administration in combination with the Swiss drugmaker’s Tecentriq in the treatment of non-small cell lung cancer.
The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
Three biopharma companies recently shuttered their clinical programs after either their drug compounds failed clinical trials or interim futility analysis suggested they were unlikely to meet their clinical endpoints.
Bristol Myers Squibb Co.’s cancer drug Opdivo plus chemotherapy helped more patients with a form of lung cancer become free of the disease versus chemotherapy alone in a late-stage trial.
Amgen presented positive topline data from the Phase II CodebreaK 100 trial of sotorasib in KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC).
