Enhertu scores FDA nod for HER2+ tumour-agnostic indications
05 Apr 2024
Clinical ResultPhase 2Priority ReviewDrug ApprovalAccelerated Approval
The FDA on Friday granted an accelerated approval to AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for certain patients with HER2+ solid tumours.
As a HER2-directed therapy, the decision covers a much larger group of patients than previous FDA tumour-agnostic approvals, which tended to focus on relatively niche biomarker-defined populations. It also marks a first tumour-agnostic approval in the US for an antibody-drug conjugate.
Specifically, the label is for adult patients with unresectable or metastatic HER2+ solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options.
The filing, which was granted a priority review in January, was based on data from the Phase II DESTINY-PanTumor02 trial, which evaluated Enhertu in previously treated patients with various HER2-expressing tumoursHER2-expressing tumours including ovarian, endometrial, biliary tract, pancreatic, and other cancers. Results showed an overall response rate (ORR) of 51.4% across tumour types, with a median duration of response (DOR) of 19.4 months, the FDA said.
Supporting data from the DESTINY-Lung01 and DESTINY-CRC02 studies were also included in the application. The first showed an ORR of 52.9% and median DOR of 6.9 months with Enhertu, while the second yielded an ORR of 46.9% and DOR of 5.5 months.
Based on the pan-tumour data available on Enhertu to date, Morgan Stanley analysts have forecasted global revenue potentially exceeding $8 billion per year.
The FDA has so far approved seven tumour-agnostic labels since the first one in 2017 – Merck & Co.'s Keytruda (pembrolizumab) for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours.
Meanwhile, the agency is in the midst of reviewing another such filing this year; Bristol Myers Squibb's Augtyro (repotrectinib) in patients 12 years and older with NTRK-positive solid tumoursNTRK-positive solid tumours that are locally advanced or metastatic, or unsuitable for surgical resection. The agency is expected to render its decision by June 15.
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