It is reported that the United States Food and Drug Administration (FDA) has sent a complete reply letter, citing additional data, refusing to approve the application of ridaforolimus (Taltorvic, produced by Merck under the authorization of Ariad Pharmaceuticals).
The oral mammalian rapamycin target protein (mTOR) inhibitor is a drug under investigation for the maintenance treatment of metastatic soft tissue or osteosarcoma patients who respond well to ≥ 4 cycles of chemotherapy.
According to the company's announcement, before considering re-applying, the drug needs to be tested for safety and effectiveness.
The FDA's decision was not surprising because in March 2012, members of the FDA Oncology Drug Advisory Committee voted against 13-1 to approve the drug. A member of the committee said that the drug's adverse reactions exceed the full benefits it brings.
According to previous reports, clinical trials have shown that ridaforolimus delayed the progression of the disease by 16.1 weeks, compared with 14 weeks for placebo. There is a slight difference between the company's calculations (17.7 vs 14.6 weeks).
Progression-free survival was increased by 2 weeks, but the risk of serious adverse events requiring treatment cessation (such as renal failure, infection, and inflammation of the lungs) increased 7-fold (14% and 2%).
Despite this, the company will persist in its efforts to obtain FDA approval.
"Merck is still confident about the potential of ridaforolimus," said Eric Rubin, MD, vice president of clinical research oncology at Merck. "We will continue to work closely with the FDA to identify potential pathways for the therapies in this study."
The oral mammalian rapamycin target protein (mTOR) inhibitor is a drug under investigation for the maintenance treatment of metastatic soft tissue or osteosarcoma patients who respond well to ≥ 4 cycles of chemotherapy.
According to the company's announcement, before considering re-applying, the drug needs to be tested for safety and effectiveness.
The FDA's decision was not surprising because in March 2012, members of the FDA Oncology Drug Advisory Committee voted against 13-1 to approve the drug. A member of the committee said that the drug's adverse reactions exceed the full benefits it brings.
According to previous reports, clinical trials have shown that ridaforolimus delayed the progression of the disease by 16.1 weeks, compared with 14 weeks for placebo. There is a slight difference between the company's calculations (17.7 vs 14.6 weeks).
Progression-free survival was increased by 2 weeks, but the risk of serious adverse events requiring treatment cessation (such as renal failure, infection, and inflammation of the lungs) increased 7-fold (14% and 2%).
Despite this, the company will persist in its efforts to obtain FDA approval.
"Merck is still confident about the potential of ridaforolimus," said Eric Rubin, MD, vice president of clinical research oncology at Merck. "We will continue to work closely with the FDA to identify potential pathways for the therapies in this study."
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