The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase II study that has successfully met its objective response rate (ORR) and duration of response (DOR) outcome measures.
Collaborative Development Efforts
The development of this therapy is a collaborative effort with Pierre Fabre, a company that holds exclusive rights to the treatment in Europe and the Asia-Pacific region, excluding Japan and South Korea. In these two countries, the local partner Ono Pharmaceutical will be responsible for commercializing the combination.
Significance of the Approval
The FDA’s approval of Braftovi and Mektovi as a combination therapy for metastatic NSCLC with a BRAF V600E mutation is a significant milestone for patients who have limited treatment options. This targeted approach offers a potential new avenue for improving outcomes in this patient population.
Conclusion
Pfizer’s regulatory approval for the Braftovi and Mektovi combination highlights the company’s commitment to expanding treatment options for patients with specific genetic mutations in their lung cancer. With a strong partnership in place, this therapy is poised to make a meaningful impact on the treatment landscape for metastatic NSCLC.-Fineline Info & Tech
