Noted This Week


April 12–18

Bristol-Myers Squibb (BMS) shareholders voted to approve the company’s acquisition of Celgene. The $74 billion merger, announced in January, had been in doubt for the past few months as large BMS shareholders such as Wellington Management, Starboard Value, and Dodge & Cox expressed opposition to the deal out of concern that investors would be accepting too much risk.

The FDA granted accelerated approval to the pan-FGFR inhibitor erdafitinib (Balversa; Janssen) for patients with locally advanced or metastatic urothelial carcinoma who have an FGFR3 or FGFR2 mutation and who have not responded to platinum-containing chemotherapy. The approval, the first for a targeted therapy for bladder cancer, was based on the phase II BLC2001 trial, in which 87 patients had an overall response rate of 32.2%. The FDA also approved Qiagen’s Therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic.

NPR reported that the first U.S. study attempting to use CRISPR to treat cancer in people is under way. The gene-editing technique has been used on a patient with multiple myeloma and a patient with sarcoma in a clinical trial at the University of Pennsylvania in Philadelphia. CRISPR studies in a variety of diseases, including sickle cell disease, Leber congenital amaurosis, and other cancers, will soon launch in Europe, the United States, and Canada.

The FDA released a draft guidance on the development of bispecific antibodies to treat cancer. The document discusses considerations such as pharmacology, manufacturing, and preclinical and clinical testing of the therapies, and delves into similarities and differences in the development of bispecific and monoclonal antibodies. Currently, blinatumomab (Blincyto; Amgen) is the only FDA-approved bispecific antibody; others are in clinical trials. The agency is accepting comments on the draft through June 17 at www.regulations.gov.

Clovis Oncology will halt the phase II ATLAS trial testing the PARP inhibitor rucaparib (Rubraca) as a monotherapy in recurrent, metastatic bladder cancer based on an independent data monitoring committee’s determination that treatment is unlikely to show a clinical benefit. The company will continue to test the drug in combinations for bladder cancer, and as a monotherapy for ovarian and prostate cancers. Rucaparib is approved as a second-line and maintenance therapy for BRCA-mutated ovarian, fallopian tube, and primary peritoneal cancers.

Tracon Pharmaceuticals is stopping the phase III TAPPAS trial testing TRC105 in combination with pazopanib (Votrient; GlaxoSmithKline) chemotherapy in advanced or metastatic angiosarcoma after an independent data monitoring committee suggested that the combination is not effective in patients. TRC105 is an endoglin antibody that previously received orphan drug designation from the FDA in soft-tissue sarcoma.


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