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April 26, 2021, 8:14 a.m. EDT

FDA to discuss whether immuno-oncology drugs with 'accelerated' approval should remain on the market

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By Jaimy Lee

The Food and Drug Administration advisory committee plans to hold a three-day meeting this week to evaluate a type of quicker approval used primarily for immuno-oncology drugs that are thought to help address unmet treatment needs among people with cancer. The FDA's "accelerated approval" process requires drug makers to conduct what are called confirmatory trials to back up the limited data used to inform the initial regulatory ok. The meeting will focus on Roche Holding AG's /zigman2/quotes/206324342/delayed CH:ROG -0.63% Tecentriq; Merck & Co Inc.'s /zigman2/quotes/209956077/composite MRK +0.06% top-selling drug Keytruda, which brought in $14.3 billion in 2020; and Bristol Myers Squibb Co.'s /zigman2/quotes/202559280/composite BMY -0.28% Opdivo, which generated $6.9 billion last year. The FDA said in documents that these drugs received additional accelerated approvals to treat different types of cancers "but subsequent confirmatory trial(s) have not verified clinical benefit ... The FDA is seeking the committee's advice on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted." The meeting is scheduled for April 27 to 29.

/zigman2/quotes/206324342/delayed
CH : Switzerland: SWX
CHF 339.35
-2.15 -0.63%
Volume: 1.13M
Sept. 21, 2021 5:30p
P/E Ratio
20.88
Dividend Yield
2.68%
Market Cap
CHF298.66 billion
Rev. per Employee
CHF574,809
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/zigman2/quotes/209956077/composite
US : U.S.: NYSE
$ 71.97
+0.04 +0.06%
Volume: 12.00M
Sept. 21, 2021 4:02p
P/E Ratio
32.85
Dividend Yield
3.61%
Market Cap
$182.08 billion
Rev. per Employee
$648,824
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/zigman2/quotes/202559280/composite
US : U.S.: NYSE
$ 60.33
-0.17 -0.28%
Volume: 10.15M
Sept. 21, 2021 4:00p
P/E Ratio
N/A
Dividend Yield
3.25%
Market Cap
$134.44 billion
Rev. per Employee
$1.41M
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