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2:58 PM
May 24, 2019
 |  BioCentury  |  Product Development

Why quizartinib hiccup at ODAC shouldn’t derail Daiichi’s 2025 cancer drug goals

Despite ODAC’s snub of quizartinib, Daiichi has several moves to make its 2025 cancer drug goals

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 trial of the candidate is already up and running. Data are expected next year.

A positive readout would keep Daiichi on track to meeting its 2025 goal. But even if the second trial fails, Daiichi’s pipeline contains 11 other clinical candidates that could pick up the slack.

The most advanced is Phase III breast cancer candidate fam-trastuzumab, a HER2-targeted ADC for which Daiichi plans to submit a BLA this half. The molecule has breakthrough designation in the U.S.

Daiichi has earmarked a pool of 10 other earlier stage candidates with potential to contribute to the 2025 tally.

Two compounds in Phase II and one in Phase I have regulatory designations that could shorten their development paths. Daiichi also has a first-in-class Phase I ADC candidate with early data that, if they hold up, could earn it a similar regulatory designation.

With quizartinib, these candidates would get Daiichi to its goal. Without quizartinib, the company would need at least one other from its earlier stage pool.

Fortunately, one of the remaining compounds is in a disease setting where Daiichi’s head of oncology has already had success in getting an approval in near record time.

Debut delay

If approved, pexidartinib and quizartinib would be the first novel cancer drugs launched by Daiichi in the U.S., although the ODAC outcome means the company’s entry into the market would likely be staggered.

Pexidartinib, a small molecule inhibitor of CSF1R, c-Kit and FLT3, won the endorsement...

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