Merck & Co., Inc. (MRK - Free Report) announced that the National Medical Products Administration (NMPA) in China has approved yet another label expansion of its blockbuster PD-1 inhibitor Keytruda (pembrolizumab). The drug is now approved in combination with chemotherapy (carboplatin and paclitaxel) for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC), a difficult to treat lung cancer population.
Following this recent nod, Keytruda in combination with chemotherapy is now approved for the first-line treatment of squamous and nonsquamous NSCLC in China. It is also approved as a monotherapy in the first-line setting for appropriate NSCLC patients with tumor proportion score ≥1%.
The approval for squamous NSCLC patients was based on data from the phase III KEYNOTE-407 study including interim data from an extension of the global study in Chinese patients. Data from the study showed that the combination of Keytruda plus chemotherapy led to a significant improvement in both overall survival (OS) and progression-free survival rates compared with patients receiving only chemotherapy in the given indication.
A similar label expansion was approved in the United States and Europe in October 2018 and March 2019, respectively. This nod will help Merck gain access to a broader lung cancer patient population in China.
Shares of Merck have rallied 14.3% so far this year, outperforming the industry’s increase of 5.9%.
Notably, Keytruda is Merck’s biggest product and already approved for 20 indications across 12 different tumor types in the United States.
The drug generated sales of almost $8 billion in the first nine months 2019, up approximately 63% year over year. Sales were driven by the launch of new indications globally. Keytruda sales are benefiting from a strong momentum in the indication of first-line lung cancer.
Moreover, Keytruda development program is progressing well and the drug is being studied for more than 30 types of cancer in above 1000 studies including 600 plus combination studies.
Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte (INCY - Free Report) , Glaxo and Pfizer (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens.
Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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