Medscape News, April 29, 2021: Two more cancer indications that had been granted accelerated approval by the US Food and Drug Administration (FDA) are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27–29) and follows a similar verdict from day one.
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NCHR Statement Regarding Cancer Drugs that Failed to Confirm Efficacy after Accelerated Approval
April 29, 2021: Patients are being harmed when the FDA does not follow the law pertaining to FDA approval. Drugs must be proven safe and effective, and companies must continue randomized clinical trials that prove the benefits of their drugs outweigh the risks for most patients.
Read More »FDA Scrutinizes Pricey Cancer Drugs
Politico Pulse, April 28, 2021: Will FDA maintain approval for cancer drugs that are proven to not work? We were hoping for a reckoning, but that doesn’t seem likely as the doctors on the FDA Advisory panel tell FDA that they are hopeful that the drugs will eventually be proven to work.
Read More »NCHR Statement at FDA Advisory Committee Meeting on Tecentriq for Triple Negative Breast Cancer
April 27, 2021: A new randomized controlled trial that includes more Black women is needed to evaluate Tecentriq for Triple Negative Breast Cancer in order to keep FDA approval. The FDA doesn’t do patients any favors by continuing to approve a treatment that isn’t shown to help and may actually harm them.
Read More »Conflicts Galore: Upcoming Accelerated Approval Cancer Panel Includes Many Industry Relationships
Pink Sheet, April 21, 2021. Six members of the FDA Oncologic Drugs Advisory Committee had conflicts of interest requiring waivers to participate in the agency’s April 2021 meeting to review whether 3 cancer drugs should have their indications for late-stage breast cancer, bladder cancer, and gastric cancer removed from the market due to lack of evidence that they are effective.
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