FDA Grants Fast-track Status to New Antibody Therapy for HER2-Positive Advanced Breast Cancer

FDA Grants Fast-track Status to New Antibody Therapy for HER2-Positive Advanced Breast Cancer

The U.S. Food and Drug Administration (FDA) has granted fast-track status to Daiichi Sankyo’s investigational therapy DS-8201a for patients with HER2-positive advanced breast cancer whose disease progressed after other HER2 therapies, such as Kadcyla (ado-trastuzumab emtansine).

Fast-track designation is meant to facilitate the development of, and expedite the review of, therapies for treating serious conditions in situations where there is an unmet medical need. The purpose is to get important new therapies to patients earlier.

“This is an important milestone for DS-8201 that underscores the critical need to develop new and effective therapeutic options for patients with metastatic breast cancer whose tumors are no longer controlled by currently approved targeted HER2 treatments,” Antoine Yver, MD, MSc, executive vice president and global head of Daiichi Sankyo’s Oncology Research and Development unit, said in a press release. “It’s our obligation to drive science forward to help bring innovative treatment options to cancer patients with the greatest unmet needs and we look forward to working closely with the FDA to optimize development of DS-8201.”

DS-8201a kills cancer cells by attaching  anti-HER2 antibodies to topoisomerase I inhibitors, which interfere with enzymes that control changes in DNA structure.

The FDA granted DS-8201a fast track on the basis of preliminary information about its safety and tolerability in patients with advanced solid malignant tumors. The data was from the increasing-dose-levels portion of an open-label, two-part, multiple-dose Phase 1 trial (NCT02564900).

The dose-escalation segment was also aimed at determining the maximum dose a patient could tolerate. Obtaining information about DS-8201s’s effectiveness and its movement through the body were secondary objectives of the trial.

Preliminary results of the dose-escalation portion of the study were presented at the European Society for Medical Oncology (ESMO) 2016 Congress Oct. 7 -11 in Copenhagen, Denmark. The poster presentation was titled “Single Agent Activity of DS-8201a, a HER2-Targeting Antibody-Drug Conjugate, in Breast Cancer Patients Previously Treated with T-DM1: Phase 1 Dose Escalation,”

The research team said it found DS-8201a to be a potent HER2 tumor fighter.  It concluded that the therapy has great potential for HER2-positive cancers that fail to respond to Kadcyla therapies, and for low HER2–expressing cancers.

Daiichi Sankyo is in the midst of enrolling patients in the U.S. and Japan in the second part of the Phase 1 trial, which will cover increases in doses. It is aimed at assessing the therapy’s safety and effectiveness.

Patients will be in one of four treatment groups: those with HER2-positive breast cancer who have been treated with Kadcyla; those with HER2-positive gastric or gastroesophageal junction adenocarcinoma who have been treated with Herceptin (trastuzumab); those with HER2 low-positive breast cancer; and those with other solid HER2-positive cancers.


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