FDA review storm results are here!

Since 2021, the FDA has successively revoked four cancer indications.

01 Tencentriq

On April 27, FDA experts discussed the indications of Tecentriq's conditionally approved combination chemotherapy drug Abraxane (albumin paclitaxel) for the treatment of PD-L1-positive triple-negative breast cancer (TNBC).

It is reported that the FDA approved Tencentriq and albumin paclitaxel for the treatment of triple-negative breast cancer based on a clinical study named "IMpassion130" in 2019.

In the discussion on the 27th, Roche received 7 votes in favor and 2 votes against, and patient needs became its "key to victory.

In addition to triple-negative breast cancer, Tencentriq has also received an "entry ticket" from experts for an indication of urothelial cancer.

In this discussion of FDA experts, Tencentriq received 10 votes in favor and 1 vote against, due to Tencentriq’s ultra-long progression-free survival period, although the clinical study of IMvigor130 has not yet obtained a clear superior overall survival result, and there is no change in the market.

02 Keytruda

Keytruda has also been “passed” for urothelial cancer.

In this review, the expert panel has 5 votes in favor and 3 votes against.

Unlike the "cautious" approval of urothelial cancer, Keytruda missed gastric cancer, with 2 votes in favor and 6 votes against, which was the first indication to be rejected in this review.

But in the field of liver cancer, Keytruda can be said to be "a big win" in this review.

But experts in favor said that “the front-line program does not guarantee the benefit of all patients.

03 Opdivo

Unlike drug K, drug O missed the field of liver cancer due to one vote in the review, with 4 votes in favor and 5 votes against.

It is reported that based on the results of CheckMate-040 clinical research earlier, Opdivo+Cabotinib and Opdivo+Cabotinib+Yervoy have shown clinically significant effects in patients with advanced liver cancer.