New breast cancer drug moves closer to India

NEW DELHI: A new breast cancer drug that can help delay the disease from worsening has moved closer to India. Camizestrant, already approved in the US, European Union, UAE and Saudi Arabia, has been recommended for import and marketing in India by a government expert panel.In a major trial, patients who switched to the drug after a change was detected in their cancer cells remained free of worsening disease for 16 months on average, compared with 9.2 months among those who continued their earlier treatment. The trial involved 315 patients and found a 56% reduction in the risk of disease progression or death.The drug is meant for adults with a common type of advanced breast cancer whose treatment has started losing effectiveness. An ESR1 mutation, which can develop during hormone treatment, can make the cancer resistant to the treatment being used.“Camizestrant could be an important new option for Indian patients with advanced breast cancer who develop an ESR1 resistance mutation during hormone treatment. A blood test can detect the mutation before the disease visibly worsens, allowing treatment to be changed earlier and potentially delaying chemotherapy,” said Dr Pragya Shukla, head of clinical oncology, Delhi State Cancer Institute.She said the bigger challenge would be making ESR1 testing affordable and accessible, particularly for patients outside major cancer centres.The recommendation was made by the Subject Expert Committee (Oncology) at its meeting at the Central Drugs Standard Control Organization (CDSCO) headquarters on September 22. The panel noted that camizestrant addressed an unmet medical need and recommended a waiver of the local Phase III trial requirement.If ultimately approved in India, camizestrant will be available only on prescription from a medical oncologist. The company has also been asked to conduct a Phase IV clinical trial and submit its protocol to CDSCO within three months of approval.The US Food and Drug Administration granted accelerated approval to camizestrant on September 4, 2026, based on the SERENA-6 trial. The FDA approval also carries warnings about irregular heart rhythm, slow heart rate and potential harm to an unborn baby.The September 22 oncology meeting also reviewed other cancer treatments. The panel sought additional safety data for an under-the-skin form of amivantamab for certain advanced lung cancers, permitted a Phase IV trial of durvalumab in Indian patients with limited-stage small-cell lung cancer, and approved a revised Phase IV trial of lutetium Lu-177 vipivotide tetraxetan with at least 80 patients. It did not waive the Phase III trial requirement for trilaciclib, citing lack of unmet need, Indian patient data and comparative evidence.You use AI every day. Now get your AI Quotient. Take the AIQ test.