publication date: Mar. 16, 2018

Drugs and Targets

Erdafitinib gets Breakthrough Therapy designation for metastatic urothelial cancer

FDA has granted Breakthrough Therapy Designation for erdafitinib in the treatment of urothelial cancer. 

The drug is sponsored by Janssen Pharmaceutical Companies of Johnson & Johnson.

The designation is based on data from a multicenter, open-label phase II clinical trial evaluating the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic urothelial cancer, whose tumors have certain fibroblast growth factor receptor genetic alterations.

The phase II study BLC2001 presented at the 2018 ASCO Genitourinary Cancers Symposium showed an overall response rate of 42 percent in 59 patients with relapsed/refractory metastatic urothelial cancer whose tumors harbored actionable FGFR mutations (ASCO-GU abstract #411).

Erdafitinib is an oral pan-fibroblast growth factor receptor tyrosine kinase inhibitor being evaluated by Janssen in phase II and III clinical trials in patients with advanced urothelial cancer. In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Therapeutics Ltd. to develop and commercialize erdafitinib.


FDA grants priority review to Merck’s sBLA for Keytruda for advanced cervical cancer

FDA has accepted a supplemental New Drug Application  and granted priority review for Keytruda  (pembrolizumab), an anti-PD-1 therapy.

The drug is sponsored by Merck.

The application seeks approval for Keytruda as a treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy. This is the first filing acceptance and priority review granted for an anti-PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA for Keytruda. The FDA has set a target action date of June 28, 2018.

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