Enhertu scores FDA nod for HER2+ tumour-agnostic indications
2024-04-05
临床结果临床2期优先审批上市批准加速审批
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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