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Merck's (MRK) Keytruda gains FDA approval for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.

 

 

Merck & Co., Inc. MRK announced that the FDA has granted approval to a supplemental new drug application (sBLA) looking to expand the label of its PD-L1 inhibitor, Keytruda.

 

Keytruda received approval for this filing, on an accelerated basis, for the treatment of advanced hepatocellular carcinoma (HCC), the most common type of liver cancer in patients, previously treated with Bayer/Amgen’s AMGN Nexavar (sorafenib). Continued approval for the indication will depend on confirmation of the clinical benefit in confirmatory studies.

 

The sBLA filing was based on data from the phase II KEYNOTE-224 study. The outcomes data from the study demonstrated that treatment with Keytruda monotherapy led to an overall response rate (ORR) of 17% in patients with advanced HCC. The data also showed a 1% complete response rate and a 16% partial response rate as a result of treatment with Keytruda.

 

So far this year, Merck’s shares have outperformed the industry. Merck’s shares have risen 33% in the period compared with 8.3% increase for the industry.

 

 

 

Keytruda is a key contributor to Merck’s sales.In a very short span of time, Keytruda has become Merck’s largest product. It is already approved for use in 12 indications across eight different tumor types in the United States.

 

The treatment generated sales of $1.89 billion in the third quarter, up 13% sequentially and 80% year over year. Sales were driven by the launch of new indications globally. 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.

 

The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 850 studies, including more than 400 combination studies. Merck is collaborating with several companies including Amgen, Incyte INCY, Glaxo GSK and Pfizer separately for the evaluation of Keytruda in combination with other regimens.

 

Keytruda is being studied in late-stage studies for breast, colorectal, esophageal, gastric, head and neck, hepatocellular, nasopharyngeal, renal and small-cell lung cancers.This year, Merck announced positive data from several late-stage studies on Keytruda for further line extensions.

 

Several regulatory decisions for new indications in the United States as well as in Europe are pending in late 2018/2019, which if approved can further boost sales. A key FDA approval last monthwas the label expansion of Keytruda as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC) – a difficult-to-treat lung cancer patient population - based on data from the phase 3 KEYNOTE-407 study.

 

Though Keytruda had its share of side effects and suffered some major pipeline setbacks, particularly in 2017, it is probably one of the most successful PD-1 and PD-L1 inhibitors in the market now.

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