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An expert committee, which advises the nation’s drug regulator on matters related to clinical trial and drug approvals, has recommended that multinational drug major AstraZeneca to submit data on Indian population from the ongoing clinical studies on its breast cancer drug trastuzumab deruxtecan, for further deliberation before deciding on marketing approval.
The Subject Expert Committee (SEC) on oncology and haematology considered the proposal presented by the company recently for import and marketing of the drug trastuzumab deruxtecan powder for concentrate solution for infusion 100 mg indicated for treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)- positive breast cancer who have received one or more prior anti-HER2-based regimens. The company requested the SEC to consider approval with local phase III clinical trial waiver.
The Committee noted that the drug product is approved in Japan, US, European Union, United Kingdom, Israel, Canada, Switzerland, Australia, Singapore, Brazil, Taiwan, Hong Kong, United Arab Emirates, and South Korea. The company has also presented the results of various clinical trials conducted in other countries.
There are around five global clinical trials ongoing related to the drug and India is also part of the trials, with 70 patients enrolled till the time of the meeting, out of around 200 patients planned from the country. The clinical trial data related to the study with Indian patients are not available, noted the committee in its meeting held on November 11, 2022.
“After detailed deliberation, the committee recommended that the firm should submit data on the Indian population from the ongoing clinical studies for further deliberation,” concluded the committee in its recommendation.
AstraZeneca, in August, this year, has said that the drug trastuzumab deruxtecan, branded as Enhertu, has been approved by the US drug regulator for the treatment of adult patients with unresectable or metastatic HER 2-low breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
The company claimed that the phase III trial showed that Enhertu reduced the risk of disease progression or death by 50 per cent versus physician’s choice of chemotherapy inpatients with HER 2-low metastatic breast cancer with hormone receptor positive or negative disease.
The expanded approval for Enhertu in the US in August, following its previous approval in 2nd-line HER2-positive metastatic breast cancer, enables its use across a wide spectrum of HER2-expressing breast cancer, including patients with HER2-low disease, said the company.
It said that the drug has been approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regiment either in metastatic setting or in the neoadjuvant or adjuvant setting and has developed disease recurrence during or within six months of completing therapy.
“A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway,” it said during the time.
Regulatory applications for Enhertu in breast, gastric and non-small cell lung cancer are currently under review in several other countries based on various global clinical trials, it added.
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