Conditional Approval Urged in EU for Trastuzumab Deruxtecan

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trastuzumab deruxtecan

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended the conditional approval of trastuzumab deruxtecan (DS-8201) for the treatment of patients with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens.

The therapy, which has received accelerated assessment in Europe, already has been approved in Japan and in the U.S., under the trade name Enhertu. The U.S. approval was granted after trastuzumab deruxtecan was granted priority review by the Food and Drug Administration.

The CHMP positive opinion will now be reviewed by the European Commission, which will decide whether to grant conditional approval.

Trastuzumab deruxtecan, developed by Daiichi Sankyo in collaboration with AstraZeneca, is an antibody-drug conjugate that targets cells carrying the HER2 protein. This conjugate is made of an HER2-specific antibody and deruxtecan, a cancer-killing agent. It is a potential treatment for all types of HER2-positive cancers, including metastatic ones that have spread to other parts of the body.

“We are encouraged by the CHMP positive opinion given the significant unmet need for patients with HER2 positive metastatic breast cancer,” Gilles Gallant, PhD, Daiichi Sankyo’s senior vice president and global head of oncology R&D, said in a press release.

“Trastuzumab deruxtecan is already available for patients with HER2 positive metastatic breast cancer in the U.S. and Japan, and we are now one step closer to bringing this important new medicine to patients in Europe,” Gallant said.

CHMP’s positive recommendation was based on results from the Phase 2 DESTINY-Breast01 trial (NCT03248492) and from a Phase 1 open label trial (NCT02564900) that tested the therapy in patients with advanced solid malignant tumors.

The DESTINY-Breast01 trial assessed the safety and efficacy of trastuzumab deruxtecan at a dose of 5.4 mg per kilogram of body weight in 253 patients with inoperable and/or metastatic HER2-positive tumors. All participants had also received at least two prior HER2 therapy regimens.

The results from the first 184 patients showed that 112 (60.9%) responded favorably to treatment. That included 103 (56%) who achieved a partial response, meaning that their tumors shrank significantly, and eight (4.3%) who achieved a complete response, indicating that their cancer disappeared.

Both the therapy’s safety and tolerability profile were without significant side effects and in agreement with that seen in the Phase 1 trial.

“The durable responses demonstrated in the DESTINY-Breast01 trial have never been seen before in this patient setting,” said José Baselga, MD, PhD, executive vice president, oncology R&D at AstraZeneca.

“If approved by the European Commission, physicians in Europe will have an important new treatment option for patients with previously treated HER2 positive metastatic breast cancer,” he added.

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