Power-Alley: Merck Gets A Coveted FDA "Fast Track" -- For Lung Oncology Candidate, sac-TMT [Sacituzumab Tirumotecan]

It seems clear that the Kelun BioTech collaboration was -- and is -- a wise one, despite the significant upfront price tags. [My prior backgrounder, one of several, from December 2022, right here.] Merck is rising nicely, on the NYSE this morning -- on the news.

The lead candidate, sac-TMT, has been conferred a "breakthrough therapy designation" at FDA and so is on the fast track for approval in specified lung cancers. Here's the latest -- but very good news for both companies:

. . .Merck said the FDA has granted Breakthrough Therapy designation for its antibody drug conjugate sacituzumab tirumotecan, also known as sac-TMT, for the treatment of a certain type of lung cancer.

Sac-TMT received the designation for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung cancer with EGFR mutations whose disease progressed on or after TKI and platinum-based chemotherapy, according to a statement. . . .

The drug is being tested as both a monotherapy and in combination with its [immuno-oncology agent] Keytruda, for the treatment of various solid tumors, as well. . . .

This, on the heels of sac-TMT being approved in China for certain hard to treat breast cancers. So this one looks to be a big win for both patients worldwide, and the Rahway multinational, now. Onward.

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