Seattle Genetics gets another drug close to the finish line
Seattle Genetics’ productive streak continues.
After closing out 2019 with its second approved drug – a potential blockbuster in Padcev – the ADC biotech then presented data showing that Padcev combined with Keytruda may be more effective than Keytruda alone for bladder cancer patients.
And on Thursday, the company announced another drug has been accepted for FDA review and has been given priority status. The drug, tucatinib, is being assessed as part of a combination treatment for locally advanced or metastatic HER2-positive breast cancer. A PDUFA date has been set for August 20, 2020.
The application to market the drug is based on positive progression-free survival and overall survival data from a Phase II trial unveiled in December: Patients given tucatinib lived about 2 months longer without their cancer returning.
Unlike the rest of Seattle’s pipeline, tucatinib is not an ADC, or an antibody-drug conjugate. Once a trendy idea, the concept fell mostly out of the news for years before Seattle Genetics’ recent success revived interest. The technology essentially uses an antibody as a kind of homing system to guide a cytotoxic drug to the tumor site.
Rather, the drug is a selective tyrosine kinase inhibitor for HER2. It did not come from in-house, but was originally developed by Array BioPharma, who licensed it to Cascadian Therapeutics. Seattle Genetics bought Cascadian for $614 million in 2018.
In addition to tucatinib and Padcev, known chemically as enfortumab vedotin, Seattle Genetics also has a Phase II ADC in collaboration with Genmab and a Phase II ADC in collaboration with Takeda.