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Did Merck Just Receive a Gift From the FDA?

By David Haen – May 1, 2020 at 8:39AM

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A new, more convenient dosing schedule favors Keytruda.

Receiving a diagnosis of cancer is scary. Undergoing treatment to fight the cancer can be just as frightening. Doing it in the midst of a global pandemic raises the stakes even further. Luckily, a new treatment regimen for certain types of cancer may halve the number of patient visits to the clinic for therapy.

Merck (MRK -0.40%) announced on April 28 that the U.S. Food and Drug Administration (FDA) had granted accelerated approval for a new treatment schedule for its marquee cancer drug, Keytruda. For context, Keytruda posted $11.1 billion in sales last year. Its closest competitor, Opdivo from Bristol Myers Squibb (BMY 0.30%), generated $7.2 billion in 2019 sales. The stakes are high for these blockbuster drugs, which have changed the cancer treatment landscape in recent years.

Arm of man receiving IV infusion

Image Source: Getty Images.

A brief history

The past decade ushered in a new era of cancer treatment aimed at harnessing the immune system. Led by a pack of antibody drugs called checkpoint inhibitors, new treatment options for a myriad of cancers became reality. Virtually every big pharma company has a checkpoint inhibitor in its stable of products, and many of these have achieved blockbuster status, raking in billions for the companies.

Bristol Myers Squibb jumped out to an early lead when Yervoy gained approval in March 2011 as a treatment for melanoma. However, the field then shifted to a new class of checkpoint inhibitors targeting proteins known as PD-1 and PD-L1. Among them was Merck's Keytruda, which gained its first approval in September 2014. Bristol Myers gained approval for Opdivo not long after, in December 2014. Opdivo sales took off, outshining Keytruda for years despite the latter's brief head start. Then in 2017, Keytruda gained momentum, finally surpassing Opdivo sales in 2018. Today, Keytruda's sales are more than 50% greater than Opdivo's.

More convenient dosing

Currently approved for a multitude of cancers, a 200 mg dose of Keytruda is given by infusion for 30 minutes once every three weeks. The new regimen, for adults only, calls for 400 mg to be administered once every six weeks.

The FDA highlighted that it granted the approval five months ahead of its goal date. The current coronavirus pandemic likely played a role in the expedited review. The new dosage halves the number of necessary visits to a transfusion center or other provider, and cancer patients, whose immune systems are likely already compromised, will thus have a reduced likelihood of exposure to COVID-19.

The dose and schedule change do not increase or decrease the overall amount of the drug sold by Merck. The new dosage will provide an attractive convenience factor for both the patient and doctor, which could lead to more patients taking Keytruda. Fewer visits also mean oncologists can treat more patients over the same period. This will be especially important for busy oncology clinics.

For comparison, the standard dosing for Opdivo is either 240 mg every two weeks or 480 mg every four weeks. Tecentriq, a checkpoint inhibitor from Roche (RHHBY 0.93%), can be infused every two, three, or four weeks depending on dose level and cancer type. Bavencio, marketed by Pfizer (PFE 0.59%) and the German pharma Merck KgaA (not to be confused with U.S. Merck), is, arguably, the most inconvenient, with a 60-minute infusion given once every two weeks.

One potential roadblock could be reimbursement. Will insurance companies want to pay for what is effectively two treatments in one visit? Will they argue that patients with advanced-stage cancer could stop responding to the drug and therefore mandate the more frequent, less convenient schedule? It's an unknown, but one that I am comfortable a big pharma like Merck is addressing.

Pharma investors should recognize that what's good for Keytruda is good for Merck. Keytruda generates more than double the revenue of Merck's next-best-selling drug, and the company has been relentless in expanding into new indications. Added convenience will likely drive new usage. This latest FDA approval should help keep Merck's crown jewel atop the field of checkpoint inhibitors.


David Haen owns shares of Pfizer. The Motley Fool owns shares of and recommends Bristol Myers Squibb. The Motley Fool has a disclosure policy.

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Stocks Mentioned

Merck & Co., Inc. Stock Quote
Merck & Co., Inc.
$85.84 (-0.40%) $0.34
Pfizer Inc. Stock Quote
Pfizer Inc.
$44.09 (0.59%) $0.26
Bristol Myers Squibb Company Stock Quote
Bristol Myers Squibb Company
$70.36 (0.30%) $0.21
Roche Holding AG Stock Quote
Roche Holding AG
$39.05 (0.93%) $0.36

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