Noted This Week
A judge in California ordered Novartis to pay $177.8 million to Plexxikon, a subsidiary of Daiichi Sankyo. The judge ruled that Novartis’s BRAF inhibitor dabrafenib (Tafinlar), which it acquired from GlaxoSmithKline and developed in collaboration with Roche, infringed on two patents Plexxikon holds for its BRAF inhibitor, vemurafenib (Zelboraf.) Both agents are FDA approved to treat melanoma; Plexxikon claimed that Novartis could only develop dabrafenib based on information it gained about vemurafenib during partnership talks.
The U.S. House of Representatives passed an appropriations package for fiscal year (FY) 2022. The package contains a bill proposing an increase of $6.5 billion for the NIH, which would bring its total budget to $49 billion. The additional funds include a $3.5 billion increase in base funding, as well as $3 billion to establish the Advanced Research Projects Agency for Health. The U.S. Senate has yet to take up appropriations bills for FY22.
Amgen will acquire Teneobio for $900 million upfront and up to $1.6 billion more in milestone payments. Amgen will gain Teneobio’s bispecific T-cell engager, TNB-585, which is in phase I testing against metastatic castrate-resistant prostate cancer, as well as the company’s bispecific and multispecific antibody technologies.
The FDA approved the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for yet another indication: It can now be combined with chemotherapy for neoadjuvant use in patients with high-risk, early-stage, triple-negative breast cancer, followed by pembrolizumab monotherapy after surgery. The approval was based on the phase III KEYNOTE-522 trial, in which patients treated with the combination had a pathological complete response rate of 63%, compared with 56% for those who received chemotherapy alone.
Bristol-Myers Squibb will stop U.S. marketing of its PD-1 inhibitor, nivolumab (Opdivo), for patients with hepatocellular carcinoma who were previously treated with sorafenib (Nexavar; Bayer/Onyx.) The decision follows an FDA advisory committee’s recommendation to remove the drug from the market for this indication due to a lack of evidence supporting its accelerated approval.
Incyte announced that the FDA declined to approve its PD-1 inhibitor, retifanlimab (INCMGA0012), for patients with locally advanced or metastatic anal cancer who have already received platinum-based chemotherapy. In a response letter to the company, the FDA stated that additional data are needed to demonstrate the clinical benefit of the drug. The response follows an FDA advisory committee’s June recommendation to defer a final decision until results of the phase III POD1UM-303 trial are available.
The FDA issued an alert that patients with multiple myeloma may have an increased risk of death if they are treated with melphalan flufenamide (Pepaxto; Oncopeptides AB) plus dexamethasone. The warning came after researchers announced that patients treated with the combination in the phase III OCEAN, Study OP-103 trial had a median overall survival of 19.7 months, compared with 25 months in those who received pomalidomide (Pomalyst; Celgene). The FDA granted accelerated approval for the combination in relapsed/refractory multiple myeloma in February.
The American Society for Radiation Oncology (ASTRO) issued recommendations for treating soft tissue sarcoma with radiation (Pract Radiat Oncol 2021 Jul 25 [Epub ahead of print]). Among other things, ASTRO strongly recommends radiation therapy before surgery over radiation after surgery for patients who require such therapy. The guidance—the first for soft tissue sarcoma—is based on a systematic review of the literature.