Power Alley: While A Bit Behind -- On The FDA Approval Calendar -- Compared To Roche's Tecentriq®, and BMS's Opdivo®, Keytruda® Scored A Win -- In A Subcutaneous (i.e., Long Acting) Delivery Form

This will undoubtedly expand the use of the blockbuster (in certain lung cancers), especially in parts of deeply-rural America (and later, around the world) -- for people who live several hours away from any major teaching hospital or cancer center. Having to drive ten hours or more -- or fly about every week -- or every other one -- can be a logistical / financial deal-breaker. This opens the probability of only making the trip once every three months.

Here's the whole story, from the irrepressible FiercePharma -- and a bit:

. . .Two months after Roche scored an FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit.

On Tuesday, company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version. . . .

[S]ubcutaneous Keytruda -- which includes Alteogen’s berahyaluronidase alfa, an enzyme used to improve the absorption and dispersion of drugs and other agents -- was given to metastatic non-small cell lung cancer patients along with chemotherapy. Another group of patients received IV Keytruda and chemotherapy. . . .

Gaining approval for subcutaneous Keytruda would expand access for the world’s best-selling drug, which racked up sales of $25 billion last year. In its IV form, Keytruda is administered at infusion centers, with the procedure taking approximately 30 minutes, every three to six weeks. . . .

Now you know -- and on, to loads of Cajun Lobster, and Shrimp tonight! Woot!

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