FDA accepts Merck application for lung cancer combo therapy




  • In Health
  • 2017-01-10 23:25:56Z
  • By Reuters

(Reuters) - 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 higher.

"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 cancers.

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)

COMMENTS

More Related News

Bristol won
Bristol won't seek faster Opdivo, Yervoy lung cancer drug approvals

Bristol-Myers Squibb Co on Thursday said it has decided not to seek accelerated U.S. approval for its combination of two immunotherapy drugs as an initial treatment for lung cancer. Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours. The pharmaceutical company cited "a review of data available at this time" for the decision to hold off on filing for approval of the combination of its cancer drugs Opdivo and Yervoy.

Prostate biopsies could be avoidable with MRIs: study
Prostate biopsies could be avoidable with MRIs: study

A quarter of men suspected of having prostate cancer could avoid invasive and potentially dangerous biopsies with the help of MRI scans, researchers reported Friday. Magnetic resonance imaging (MRI) could also reduce the number of men over-diagnosed with the disease by five percent, they detailed in a study published in The Lancet. In the case of prostate cancer, "over-diagnosed" includes relatively benign cancers that do not cause any harm during a man's lifetime.

Bristol-Myers won
Bristol-Myers won't seek accelerated Opdivo lung cancer approval

(Reuters) - Bristol-Myers Squibb Co on Thursday said it has decided not to seek accelerated U.S. approval for its combination of two immunotherapy drugs as an initial treatment for lung cancer. Bristol cited "a review of data available at this time" for the decision to hold off on filing for approval of the combination of its cancer drugs Opdivo and Yervoy. Merck last week said U.S. regulators had agreed to an accelerated review of its application to combine immune system-boosting drug Keytruda with chemotherapy as an initial therapy for advanced lung cancer.

1 in 4 US men have cancer-linked HPV genital infections
1 in 4 US men have cancer-linked HPV genital infections

CHICAGO (AP) - The first national estimate suggests that nearly half of U.S. men have genital infections caused by a sexually transmitted virus and that 1 in 4 has strains linked with several cancers.

Merck CEO sees Keytruda in pole position in cancer race
Merck CEO sees Keytruda in pole position in cancer race

By Ben Hirschler DAVOS, Switzerland (Reuters) - Merck & Co's Keytruda cancer drug, which last week won a speedy review from U.S. regulators for use with chemotherapy in lung cancer, is in an increasingly strong position in a fiercely competitive market, the company's CEO said on Thursday. Chief Executive Ken Frazier said that Keytruda would also be cheaper than some rival approaches -- an increasingly important consideration in an era of heightened controversy about high drug prices. The U.S. Food and Drug Administration (FDA) is due to decide by May 10 whether to approve a combination of the immune system-boosting drug with chemotherapy as an initial therapy for advanced...

Leave a Comment

Your email address will not be published. Required fields are marked with *

Cancel reply

Comments

Top News: Health

facebook
Hit "Like"
Don't miss any important news
Thanks, you don't need to show me this anymore.