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)


More Related News

Budget Cuts Could Lead to More Radon Deaths
Budget Cuts Could Lead to More Radon Deaths

In 2010, Gail Orcutt was diagnosed with lung cancer. The diagnosis came as a shock to the nonsmoker, who eventually had her entire left lung removed. She had no idea how she could have developed the disease until she came across an article about radon and learned it was the top cause of lung cancer among nonsmokers. She also discovered that her state, Iowa, has particularly high levels of radon, so she immediately had her home tested and found elevated levels. Remediation, the removal of radon from her home, was a simple process that took one day and left her wishing she had done it years ago. ...

U.S. FDA approves Takeda
U.S. FDA approves Takeda's lung cancer drug as second-line treatment

(Reuters) - Japan's Takeda Pharmaceutical Co Ltd said on Friday that the U.S. Food and Drug Administration approved its lung cancer drug, almost three months after the company acquired the drug's developer, Ariad Pharmaceuticals Inc. The drug, Alunbrig, is approved as a second-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer, who have progressed on or are intolerant to Pfizer's crizotinib, the standard initial treatment for the disease. Alunbrig was approved under the FDA's accelerated approval program, which allows for quicker approval of drugs that fill an unmet medical need. Takeda in mid-February completed its...

Beware of Bogus Cancer Treatments, FDA Says
Beware of Bogus Cancer Treatments, FDA Says

Americans should be wary of products claiming to treat or cure cancer, as a number of products are falsely making these claims, according to the Food and Drug Administration. Today (April 25), the FDA sent warning letters to 14 U.S. companies saying that the businesses are breaking the law by making unproven claims about their products. "Consumers should not use these or similar unproven products, because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment," Douglas Stearn, director of the Office of Enforcement and Import Operations at the FDA, said in a statement.

Leave a Comment

Your email address will not be published.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

Cancel reply


Top News: Health

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