BeiGene (NASDAQ: BGNE) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended its programmed death-1 (PD-1) inhibitor tislelizumab for a marketing license for three non-small cell lung cancer (NSCLC) indications. The CHMP’s positive opinion is for:
- First-line treatment of locally advanced or metastatic squamous NSCLC in adult patients ineligible for surgical resection or platinum-based radiotherapy and chemotherapy, to be used in combination with paclitaxel plus carboplatin or injectable paclitaxel (albumin binding type) plus carboplatin.
- First-line treatment of locally advanced or metastatic NSCLC with PD-L1 expression of ≥ 50%, and without positive mutations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK), in combination with pemetrexed and platinum-based chemotherapy.
- Monotherapy for adult patients with locally advanced or metastatic NSCLC who have previously received platinum-containing drug therapy.
Patients with EGFR or ALK mutation-positive NSCLC must have received targeted therapy prior to treatment with tislelizumab.
This recommendation is supported by data from three Phase III studies involving 1,499 patients: the RATIONALE 307 study on tislelizumab as a first-line treatment for advanced squamous NSCLC, the RATIONALE 304 study on tislelizumab for first-line treatment of non-squamous NSCLC, and the RATIONALE 303 study on tislelizumab as a second-line treatment for advanced NSCLC. All studies demonstrated clinical benefits.
BeiGene has submitted 15 indication approval filings for tislelizumab to China’s Center for Drug Evaluation (CDE), with 12 approvals granted to date, and 11 of these indications are covered by the National Reimbursement Drug List (NRDL).- Flcube.com
