FDA's ODAC may have given the thumbs down to Daiichi’s quizartinib, but a stocked pipeline and another ongoing trial of the candidate suggest it’s more of a hiccup than a hurdle in the Japanese pharma’s goal of launching seven new cancer drugs by 2025.
While Daiichi Sankyo Co. Ltd. has traditionally focused on cardiometabolic disorders, the company has been making moves over the last three years to stake out space in oncology, including adding key R&D leaders, building out its antibody-drug conjugate (ADC) platform and striking a dozen in-licensing deals.
It kicked off the push in 2016 by establishing the Daiichi Cancer Enterprise, a “company-wide effort and commitment to help accomplish” its objective of getting seven NMEs to either the U.S., EU or Asian market between 2018 and 2025, spokesperson Jennifer Brennan told BioCentury in an emailed response.
The first two of these therapies are now under review at FDA and both came in front of the Oncologic Drugs Advisory Committee (ODAC) on May 14.
The outcome was split. The efficacy and lack of available treatments swayed the panel to support approval of pexidartinib to treat tenosynovial giant cell tumor (TGCT), but marginal efficacy and an imbalance in arms due to missing data led the panel to vote against quizartinib, instead recommending a second trial of the AML candidate (see "Daiichi Gets ODAC Split, with FDA Panel Backing Pexidartinib for Rare Cancer").
The ODAC outcome may only delay quizartinib’s debut.
The ODAC outcome may only delay quizartinib's debut, however, as a second Phase III