UK Markets closed
  • FTSE 100

    +59.96 (+0.92%)
  • FTSE 250

    +50.25 (+0.25%)
  • AIM

    +2.67 (+0.25%)

    +0.0009 (+0.08%)

    -0.0015 (-0.1088%)

    -22.94 (-0.16%)
  • CMC Crypto 200

    -14.05 (-3.71%)
  • S&P 500

    +32.40 (+0.88%)
  • DOW

    +248.74 (+0.83%)

    +0.45 (+0.99%)

    +0.90 (+0.05%)
  • NIKKEI 225

    -58.13 (-0.22%)

    +107.42 (+0.40%)
  • DAX

    +46.10 (+0.35%)
  • CAC 40

    +34.79 (+0.62%)

Merck's Keytruda Gets Accelerated Approval for Solid Tumors

Zacks Equity Research
·3-min read

Merck & Co., Inc. MRK announced that the FDA has approved a supplemental biologics license application (sBLA) for its blockbuster PD-1 inhibitor, Keytruda, under accelerated approval pathway. The sBLA sought approval of Keytruda as a monotherapy in adult and pediatric patients whose unresectable or metastatic solid tumors are tumor mutational burden-high (TMB-H) and who have progressed following prior treatment and have no satisfactory alternative treatment options.

Keytruda is the first checkpoint inhibitor to receive approval for this indication. This is also the second biomarker-based indication for the drug, regardless of tumor type. In 2017, the FDA had approved Keytruda as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. The approval was also based in part on data from the KEYNOTE-158 study.

Please note that continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory studies.

The FDA has also approved companion diagnostic test — FoundationOne CDx — to identify patients with solid tumors that are TMB-H.

The accelerated approval was based on data from the KEYNOTE-158 study evaluating patients with various previously treated unresectable or metastatic solid tumors with TMB-H. However, it excluded patients who were previously treated by an anti-PD-1 or other immune-modulating monoclonal antibody, or who had an autoimmune disease, or a medical condition that required immunosuppression. A prospectively-planned retrospective analysis of 10 cohorts from the KEYNOTE-158 study showed that Keytruda has achieved an objective response rate of 29%.

Merck’s shares have declined 16.1% this year so far, compared with the industry’s 2.5% decline.


Keytruda, Merck’s biggest product, is already approved for use in more than 20 indications across several different tumor types in the United States.

Keytruda recorded sales of $3.3 billion in the first quarter of 2020, up 44.7% year over ear. The drug’s sales were driven by the launch of new indications globally. Keytruda sales, particularly, are benefiting from strong momentum in the first-line lung cancer indication.

The Keytruda development program is also progressing well with Merck spending billions on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in over 1200 studies including 600 plus combination studies. Merck is collaborating with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.

Undoubtedly, Keytruda’s solid growth prospects are based on increased utilization, approval for new indications and expectation of additional approvals worldwide.

Merck Co., Inc. Price


Merck  Co., Inc. Price
Merck Co., Inc. Price

Merck Co., Inc. price | Merck Co., Inc. Quote

Zacks Rank

Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Zacks’ Single Best Pick to Double

From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.

This young company’s gigantic growth was hidden by low-volume trading, then cut short by the coronavirus. But its digital products stand out in a region where the internet economy has tripled since 2015 and looks to triple again by 2025.

Its stock price is already starting to resume its upward arc. The sky’s the limit! And the earlier you get in, the greater your potential gain.

Click Here, See It Free >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Pfizer Inc. (PFE) : Free Stock Analysis Report
Merck Co., Inc. (MRK) : Free Stock Analysis Report
GlaxoSmithKline plc (GSK) : Free Stock Analysis Report
Amgen Inc. (AMGN) : Free Stock Analysis Report
To read this article on click here.