Betta Pharmaceuticals Announces NMPA Approval of Ensartinib for Adjuvant Treatment of ALK-Positive NSCLC in China

Betta Pharmaceuticals Announces NMPA Approval of Ensartinib for Adjuvant Treatment of ALK-Positive NSCLC in China Xcovery Holdings, Inc. today noted that its partner, Betta Pharmaceuticals, has announced that China’s National Medical Products Administration (NMPA) approved ensartinib hydrochloride for adjuvant treatment following surgical resection in patients with ALK-positive stage IB–IIIB non-small cell lung cancer (NSCLC), with or without adjuvant chemotherapy as determined by the treating physician. The approval is based on results from ELEVATE, a multicenter, randomized, double-blind Phase 3 registrational study conducted in China evaluating ensartinib versus placebo in patients with resected ALK-positive NSCLC. In ELEVATE, ensartinib demonstrated a statistically significant improvement in disease-free survival (DFS) compared with placebo in the prespecified study populations. This regulatory approval applies to China. About ELEVATE ELEVATE is a randomized, double-blind Phase 3 study conducted at 56 medical centers in China. The study evaluated ensartinib as adjuvant therapy following complete surgical resection in patients with ALK- positive stage IB–IIIB NSCLC. Disease-free survival was the primary efficacy measure described in Betta Pharmaceuticals’ announcement. About Ensartinib / ENSACOVE® Ensartinib is an ALK inhibitor developed for the treatment of ALK-positive NSCLC. In the United States, ensartinib is marketed as ENSACOVE®. U.S. healthcare professionals and patients should refer to the current U.S. Prescribing Information for the FDA-approved indication and complete safety information.

The release as fetched from its publisher. xcovery.com ↗