Faster FDA approvals lead to cancer drug boom
The Food and Drug Administration (FDA) is approving new drugs – especially those to treat cancer – at a near record pace this year.
FDA is approving new drugs – especially those to treat cancer – at a near record pace this year.
Related: FDA approves additional indication for Opdivo
As of March 19, the agency approved 10 new drugs, which is on pace to match last year’s total of 41, an 18-year high, Bloombergreported. Between 2010 and 2014, the FDA approved 37 cancer drugs, compared to just 19 between 2005 and 2009. It has approved 4 additional medications so far in 2015.
This year’s approvals include the first treatment for advanced breast cancer approved in years. In early February, FDA approved Pfizer Inc.’s palbociclib (Ibrance), after a small trial showed the drug could slow the spread of advanced breast cancer. The FDA approved the drug more than two months ahead of schedule. In the past, approval could have taken years longer, because the agency might have insisted on additional trials first, Pfizer R&D head Mikael Dolsten told Bloomberg.
Related: FDA speends up drug, device approvals
In addition, Merck & Co. said that a trial for its skin cancer drug pembrolizumab (Keytruda) was stopped early because patients who received it as a first treatment for advanced melanoma lived longer than those receiving standard therapy.
FDA also approved the expanded use of nivolumab (Opdivo), a skin-cancer drug from Bristol-Myers Squibb Co., to treat lung cancer in early March.
Read more: Details about Opdivo's studies, cost, implications
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
Read More
