WHITEHOUSE STATION (dpa-AFX) - Merck & Co. Inc. (MRK) said Tuesday that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for ridaforolimus, an investigational oral mTOR inhibitor under development for maintenance therapy for patients with metastatic soft tissue or bone sarcoma who have stable disease or better after four or more cycles of chemotherapy.
The complete response letter states that FDA cannot approve the application in its present form, and that additional clinical trial(s) would need to be conducted to further assess safety and efficacy.
'Merck remains confident in the potential of ridaforolimus,' said Eric Rubin, M.D., vice president, Clinical Research Oncology, Merck. 'We will continue to work closely with the FDA to define potential paths forward for this investigational therapy.'
Merck also said it is in ongoing talks with health authorities in Europe and other countries as part of their application procedures for ridaforolimus for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy.
Additionally, Merck is studying ridaforolimus in combination with other mechanisms in several tumor types.
As part of an exclusive license agreement with ARIAD Pharmaceuticals, Inc (ARIA), Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology.
In March, an FDA advisory panel decided not to recommend for approval of ridaforolimus to treat soft tissue sarcoma. The panel voted 13 to 1 against the use of ridaforolimus (Taltorvic) to treat patients with metastatic soft-tissue sarcoma or bone sarcoma in patients who had undergone chemotherapy.
Copyright RTT News/dpa-AFX
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