May 6, 2021: Although AAV is a serious disease with an unmet need for new treatments, avacopan has not clearly demonstrated that it is more effective than the existing treatments, and it apparently carries more risk for certain adverse events.
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NCHR Statement at FDA Advisory Committee Meeting on Keytruda and Tecentriq for Advanced Urothelial Carcinoma
April 28, 2021: Patients have suffered from taking cancer drugs that aren’t proven to work. Other treatment options are proven to work. Physicians can still choose whatever treatments are on the market, but treatment decisions shouldn’t be based on the mistaken belief that these drugs are proven effective for advanced urothelial carcinoma.
Read More »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 »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 »NCHR’s Testimony at FDA Regarding Donislecel Treatments for Diabetes
April 15, 2021: We agree with the concerns of the FDA reviewers regarding the benefit-risk profile of donislecel transplant treatments.
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