CHMP recommends eight new drug approvals, six label expansions

It was a positive week for the European Medicines Agency’s human medicines committee (CHMP), which recommended the approval of eight new drugs including Takeda’s Fruzaqla and AstraZeneca’s Truqap.

The committee also voted in favor of six new label expansions. While the European Commission has the final authority over new drug approvals, it typically follows CHMP’s recommendations.

The approval recommendations include:

Fruzaqla, or fruquintinib, which has been approved in China since 2018. But last January, Takeda offered Hutchmed $400 million upfront for the rights outside of China, Hong Kong and Macau. The drug was approved in the US in November for previously-treated patients with metastatic colorectal cancer. At the time, global oncology president Teresa Bitetti touted Fruzaqla as the first “chemotherapy-free treatment option approved for patients in the US regardless of biomarker status in more than a decade.”

AstraZeneca’s Truqap also…
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