See the DrugPatentWatch profile for polivy

To summarize the data used to approve Polivy, a drug used for treating certain types of cancer, I will provide a concise and informative answer based on the provided sources.

Polivy, developed by Genentech, is a drug used for treating diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. The U.S. Food and Drug Administration (FDA) approved Polivy in June 2019, based on a clinical trial demonstrating its safety and efficacy [1].

The FDA's accelerated approval process allows for the approval of drugs that treat serious conditions, where there is an unmet medical need [2]. Polivy was granted this accelerated approval, supported by the data from a phase Ib trial [1].

The trial included 32 adult patients with relapsed or refractory DLBCL, who had received at least two prior therapies [1]. The results showed that 40% of patients responded to Polivy, with 15% achieving a complete response [1].

The National Institutes of Health (NIH) has provided guidelines for clinical trials, which aim to protect the rights, safety, and welfare of human subjects [3]. These guidelines ensure that the data used for drug approvals, such as Polivy, are reliable and ethically obtained [3].

In summary, Polivy was approved by the FDA for treating DLBCL based on a phase Ib trial, which demonstrated its safety and efficacy in patients who had received at least two prior therapies. The FDA's accelerated approval process and NIH's guidelines for clinical trials ensured the ethical and reliable collection of data used for Polivy's approval.

Sources:
[1] <https://www.drugpatentwatch.com/p/biologics/tradename/POLIVY>
[2] <https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html>
[3] <https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html>