Venetoclax Breakthrough Designation, Zarxio Legal Update, and More

The FDA approved dostarlimab in rectal cancer and pembrolizumab in tumors with high mutational burden, Europe cleared teclistamab in myeloma, and more.

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The claudin 6–targeted antibody-drug conjugate ixotatug vedotin showed antitumor activity in recurrent germ cell tumors, including after transplant.

The sacituzumab govitecan, enfortumab vedotin, and zimberelimab triplet produced early, durable responses in untreated metastatic urothelial cancer.

Efficacy outcomes in KEYNOTE-905 were consistent with a contribution of both enfortumab vedotin and pembrolizumab in cisplatin-ineligible MIBC.

The FDA has granted traditional approval to pembrolizumab for unresectable/metastatic TMB-H solid tumors.

Lisaftoclax plus acalabrutinib earned breakthrough therapy status in China for untreated CLL/SLL.

Updated ARC-20 data showed casdatifan activity as monotherapy and in combinations across treatment lines in advanced clear cell RCC.