Jan 10 Merck & Co on Tuesday said the
FDA agreed to a speedy review of its application to combine its
immunotherapy drug Keytruda with chemotherapy as an initial
treatment for advanced lung cancer, potentially giving it a
major leg up in the competition for the largest cancer market.
Merck said the U.S. Food and Drug Administration would
decide by May 10 whether to approve the Keytruda combination
therapy, sending the drugmaker's shares more than 3 percent
"This comes as an important surprise because if FDA approves
the application, Merck would suddenly be catapulted ahead of all
other (immunotherapy) competitors who are also pursuing
competing combination regimens of their own," Bernstein analyst
Tim Anderson said in a research note, mentioning Roche,
Bristol-Myers Squibb and AstraZeneca.
Merck had not previously indicated that it was close to
filing for the combination therapy. Industry analysts had been
looking for this news toward the end of the year.
Keytruda alone is already approved as an initial, or
first-line, treatment for advanced lung cancer in patients whose
tumors have a high level of PD-L1 expression, the protein that
the drug targets to help the immune system fight cancer.
This first application for Keytruda in combination with
another medicine would include patients with metastatic or
advanced non-squamous non-small cell lung cancer (NSCLC)
regardless of PD-L1 expression level, opening up a much larger
market for the medicine.
Patients with high PD-L1 expression account for only about a
quarter of all lung cancer patients.
Evercore ISI estimated the market for first-line lung cancer
for all patients could be as high as $14 billion.
"While Merck is unlikely to durably penetrate this entire
population, especially with multiple competing regimens on the
horizon, an approval in May would give them a significant
first-mover advantage," Evercore analyst John Scotti wrote.
Keytruda is already also approved to treat advanced
melanoma, the deadliest of skin cancers, and head and neck
Merck shares rose to $62 in extended trading from a New York
Stock Exchange close at $59.92.
(Reporting by Bill Berkrot; Editing by James Dalgleish)