Tanja Obradovic: Era of antibody drug conjugates just got even more exciting with the first tumor-agnostic approval for ADC
Tanja Obradovic,
“Era of antibody drug conjugates (ADCs) just got even more exciting with the first tumor-agnostic approval for ADC. Enhertu, is a HER2-directed ADC discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
As of April 5th, it has 5 approved indications with the latest addition of very impressive tumour-agnostic approval by FDA as a HER2-directed therapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Development and successful approval is great example of coordinated product development across portfolio of Phase II trials and leveraging data (results from the subgroup of patients with HER2-positive IHC 3+ tumors in each of the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 Phase II trials).
FDA has recognized value of programatic development strategy and global importance of synchronized regulatory evaluation in Oncology so this tumor-agnostic Enhertu review was conducted under Project Orbis. Project Orbis is an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of Oncology drugs among international partners.
In this case, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, and Singapore’s Health Sciences Authority (HSA) while review is still ongoing at other Agencies.
Amazing development for patients with global impact and increased importance for widely applied HER2 testing as a standard.”
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Source: Tanja Obradovic/LinkedIn
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