What This FDA Delay Means for Novartis
Swiss pharmaceutical giant Novartis (NYSE: NVS) prides itself on the breadth and depth of its oncology portfolio. Despite this, the company has failed to offer a drug in a specific class of treatments known as PD-1 inhibitors, causing it to miss out on large and highly lucrative market opportunities. A month ago, Novartis appeared to be on the verge of addressing this gap, but now must wait a little longer to hear the Food and Drug Administration's (FDA) verdict.
After watching from the sidelines for the past decade as Merck's Keytruda and Bristol Myers Squibb's Opdivo generated mega-blockbuster sales, Novartis finally looked set to introduce its own competing drug into the market. Last year, Novartis bought partial rights to BeiGene's tislelizumab, a monoclonal antibody that blocks the PD-1 protein to help the immune system recognize and destroy cancer cells. The $650 million deal gave Novartis rights to market the drug in North America, Europe, and Japan.
Novartis hopes that the drug will ultimately be approved for multiple indications. Tislelizumab is already approved in China for the throat cancer indication under FDA review, as well as for several other cancers, including Hodgkin lymphoma, and certain lung and bladder cancers. Novartis has 17 pivotal clinical trials underway across a wide spectrum of solid tumors, and it already has regulatory applications submitted for non-small cell lung cancer and throat cancer.
Source Fool.com
