The FDA has granted Priority Review for AstraZeneca and Daiichi Sankyo’s supplemental BLA for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors.
Pictured: AstraZeneca signage at its facility in Gothenburg, Sweden/iStock, Wirestock
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted Priority Review for a supplemental BLA for the treatment of adults with unresectable or metastatic HER2 positive solid tumors, who have received prior treatment or who have no satisfactory alternative treatment options.
According to Monday’s release, the PDUFA date is set for May 30, 2024. Enhertu was already granted a Breakthrough Therapy Designation by the FDA in August 2023. The sBLA is also based on data from the Destiny-PanTumor02 Phase II trial in which Enhertu has shown “clinically meaningful” and “durable” responses showing a survival benefit in patients, according to the companies. Data from several other clinical programs will also be used.
“The clinical benefit seen across HER2 expressing metastatic solid tumors in the DESTINY-PanTumor02 trial and ongoing data from the Enhertu clinical development program continues to demonstrate the potential of this medicine beyond its approved indications,” Ken Takeshita, Daiichi Sankyo’s global head of R&D, said in a statement. “If approved, Enhertu could become the first HER2-directed therapy and antibody-drug conjugate with a tumor agnostic indication, providing patients with a potential new treatment option.”
According to the results of the Destiny trial, posted in the Journal of Clinical Oncology, the overall response rate was 37.1%, with responses occurring in seven tumor groups.
The median progression-free survival (PFS) rate was 6.9 months, with the median overall survival at 13.4 months.
“Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. We will continue working closely with the FDA to bring this potential first tumor agnostic HER2 targeted medicine to patients as quickly as possible,” Susan Galbraith, executive vice president of oncology at AstraZeneca, said in a statement.
Soon after Enhertu’s approval to treat breast cancer in 2022, both companies announced a successful Phase III for the treatment, showing clinically meaningful improvement in PFS for patients with HER2-positive unresectable and metastatic breast cancer who had previously been treated with trastuzumab emtansine (T-DM1).
In December 2023, Enhertu was also given two Breakthrough Therapy Designations for adults with unresectable or metastatic HER2 positive solid tumors that have progressed following prior treatment and who have no alternatives and for patients with HER2 positive metastatic colorectal cancer who have received two or more prior therapies.
In the third quarter of 2023, the ADC pulled in $73 million in sales and $178 million in total sales for the year up to that point.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
