) recently received a complete response letter (CRL) from the US
Food and Drug Administration (FDA) for its oncology candidate,
ridaforolimus. Merck is looking to get ridaforolimus approved as a
maintenance therapy for patients with metastatic soft-tissue
sarcoma or bone sarcoma whose disease has not progressed or has
improved after at least four cycles of chemotherapy.
The FDA said that the company needs to conduct additional trials
evaluating the safety and efficacy of ridaforolimus. The agency
said that the candidate cannot be approved based on the submitted
Merck intends to work with the FDA to determine the regulatory
path for ridaforolimus. Meanwhile, the company is in discussions
with regulatory agencies in the EU and other countries where it is
seeking approval for the candidate.
The FDA's decision and requirement for additional studies is not
surprising. Earlier this year, the FDA's Oncologic Drugs Advisory
Committee (ODAC) had voted (13-1) against the drug. In its briefing
documents, the FDA had asked the committee to analyze the
risk-benefit profile of ridaforolimus given the small differences
in median progression free survival (PFS) and overall survival (OS)
between the ridaforolimus and placebo arms and ridaforolimus'
adverse event profile. Given the concerns regarding ridaforolimus'
safety and efficacy, we were not optimistic about ridaforolimus'
chances of gaining first-round approval.
) have an exclusive licensing agreement for ridaforolimus. While
Merck is responsible for the development and worldwide
commercialization of ridaforolimus in oncology, ARIAD will
co-promote ridaforolimus in the US.
We currently have a Neutral recommendation on Merck, which
carries a Zacks #3 Rank (short-term "Hold" rating).
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