Merck & Co., Inc. (MRK – Free Report) announced FDA’s accelerated approval for its PD-1 inhibitor, Keytruda as a third-line treatment for adult as well as pediatric patients with primary mediastinal B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma.
The company will need to evaluate the drug in confirmatory studies in this indication for gaining continued approval.
This is the second indication for which Keytruda has gained FDA approval this week. On Tuesday, Keytruda gained FDA’s accelerated approval for advanced cervical cancer in second-line setting. These label expansion approvals should drive sales of Keytruda in the future quarters.
With the latest approval, Keytruda became the first anti-PD-1 therapy approved in PMBCL. This is also the second indication for Keytruda for a hematologic malignancy, the first being refractory classical Hodgkin lymphoma (cHL) for which FDA approval was received in March 2017. The approval was based on data from KEYNOTE-170 study.
This year so far, Merck’s shares have outperformed the industry. Its shares have risen 11.2% in the period against the industry’s decline of 4.4%.
Keytruda is the largest product in Merck’s portfolio. Prior to the latest approvals, Keytruda was approved for use in 10 different settings involving seven different tumor types.
The treatment generated sales of $1.5 billion in first-quarter 2018, up 12.9% sequentially and 151% year over year. This upside was driven by the global launch of indications, which further boosted demand. Keytruda sales are gaining, particularly from strong momentum in the first-line lung cancer indication. In fact, Keytruda is the only anti-PD-1 approved in the first-line setting for certain lung cancer patients both as a monotherapy as well as a combination therapy with Eli Lilly’s (LLY – Free Report) cancer drug, Alimta (pemetrexed) and carboplatin (pem/carbo).
At the recently concluded annual meeting of the American Society of Clinical Oncology, this PD-L1 inhibitor stole the limelight with encouraging data from multiple clinical studies. The data presentation from Merck, which garnered the most attention from physicians and investors was from a second interim analysis of a pivotal lung cancer study on Keytruda — phase III KEYNOTE-407 study.
Keytruda is being studied for more than 30 types of cancer in more than 700 studies, including in excess of 400 combination studies. Merck is collaborating with several companies including Amgen (AMGN – Free Report) , Incyte, Glaxo (GSK – Free Report) and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
In a separate press release, Merck announced that its supplemental biologics license application (sBLA) seeking approval for an expanded age indication for its HPV vaccine Gardasil was granted priority review by the FDA.
The sBLA is aimed at getting Gardasil approved for women and men aged 27 to 45 for the prevention of certain HPV-related cancers and diseases. The vaccine is presently indicated for men and women 9 through 26 years of age.
The FDA has set an action date of Oct 6. In the first quarter of 2018, Gardasil/Gardasil 9 recorded sales of $660 million, up 24% year over year
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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