logo
Plus   Neg
Share
Email

Merck KGaA: FDA Granted Breakthrough Therapy Designation For Tepotinib

German science and technology company Merck KGaA (MKGAY.PK) announced Wednesday that the US Food and Drug Administration has granted Breakthrough Therapy Designation for the investigational targeted therapy tepotinib.

The therapy is for patients with metastatic non-small cell lung cancer or NSCLC harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy.

Discovered in-house at Merck KGaA, tepotinib is an investigational oral MET kinase inhibitor.

The Breakthrough Therapy Designation is based on data from the ongoing VISION study (NCT02864992), showing preliminary clinical evidence that tepotinib may offer an improvement over available therapy.

Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck KGaA, said, "Tepotinib was associated with robust objective responses with durability that has not previously been seen in patients with metastatic NSCLC harboring MET exon 14 skipping alterations, selected by either tissue or liquid biopsy approaches."

In March 2018, the Japanese Ministry of Health, Labour and Welfare granted SAKIGAKE 'fast-track' designation for tepotinib in advanced NSCLC harboring MET exon 14 skipping alterations.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Google announced a batch of renewable energy deals totaling 1.6 GW through 18 acquisitions spread across three continents. The deals are intended to "spur the construction of more than $2 billion in new energy infrastructure," the company said. Google said the deals will increase its worldwide portfolio... Beyond Meat's main competitor Impossible Foods will launch its grocery store in California on Friday. Beyond Meat Inc. (BYND), the meatless burger and sausage maker, announced the appointment of Sanjay Shah as Chief Operating Officer. Shah will assume the responsibility for Beyond Meat's global operations and production, effective September 18.
Follow RTT
>