Otsuka wins early FDA approval for a colorectal cancer combo drug

Japanese drugmaker Otsuka won FDA approval for a two-drug therapy for colorectal cancer, planning to market the combination as a treatment for advanced forms of the disease.

The treatment, developed as TAS-102, combines the cancer-killing trifluridine with tipiracil, an agent designed to block enzymes that protect tumors from its partner chemical. The FDA cleared TAS-102 to treat refractory metastatic colorectal cancer, approving the therapy for patients whose tumors have spread despite first-line therapies.

Otsuka's drug met its goals in a Phase III study on 800 patients with previously treated metastatic colorectal cancer, beating placebo in extending progression-free survival, the FDA said.

The agency's approval comes almost three months ahead of schedule, underscoring the FDA's longstanding penchant for speedily signing off on new cancer treatments for the most dire patient populations.

The combo therapy is already on the market in Japan under the brand name Lonsurf. Otsuka submitted its treatment for European review in March, and the company has since signed a $130 million partnership with Servier that tasks the French drugmaker with marketing the drug on the continent.

- read the statement

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.