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SEC recommends approval for additional indication of AstraZeneca's anti-cancer drug
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Gireesh Babu, New Delhi
November 03 , 2026
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The Subject Expert Committee (SEC), which advises the central drug regulator on clinical trials and approval of new drugs, has recommended approval for AstraZeneca Pharma's anti-cancer drug datopotamab deruxtecan powder for concentrate for solution for infusion 100 mg for additional indication with phase III clinical trial waiver.
The recommendation is based on a proposal from the company for approval of additional indication for the drug indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The company also requested a local phase III clinical trial waiver.
The SEC (oncology), considering the request, noted that this additional indication is approved in the USA, Russia and Brazil. The committee further noted that the firm has conducted global clinical trial study for the proposed indication which includes Indian patient dataset.
"Also, till date 226 Indian patients have participated in 9 global clinical trials of Datopotamab Deruxtecan," it added.
"After detailed deliberation, the committee recommended for the considered for approval of the proposed indication with phase III CT waiver along with conditions to conduct phase IV clinical trial in India in the proposed additional indication," added the Committee.
It sought the firm to submit phase IV clinical trial protocol to the drugs regulator within three months from the grant of approval.
It may be noted that in December, 2025 AstraZeneca Pharma India Ltd announced that it has received the regulatory approval from Central Drugs Standard Control Organisation (CDSCO) to import, sell, and distribute Datopotamab Deruxtecan (Dato-DXd) in India.
Dato-DXd is a novel, TROP2-directed antibody drug conjugate (ADC) developed for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
The approval supported AstraZeneca’s focus on bringing to life-changing medicines at a rapid pace and marks its second antibody–drug conjugate (ADC) approval in India after trastuzumab deruxtecan (T-DXd), it said.
During the announcement, the company said that breast cancer is the most diagnosed cancer globally, with over 2.3 million cases recorded in 2022 according to the World Health Organization (WHO).
In India, the burden continues to grow rapidly, incidence rates have risen by nearly 40% over the past 25 years, making breast cancer the most prevalent cancer among Indian women. Many patients are diagnosed at an advanced stage, where treatment options remain limited and outcomes often poor.
Datopotamab deruxtecan, branded as Datroway in the US, is discovered by Daiichi Sankyo and jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
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