AstraZeneca Pharma India receives CDSCO approval for HER2-positive stage II or III early breast cancer treatment

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AstraZeneca Pharma India has announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for trastuzumab deruxtecan 100 mg/5 mL vial lyophilised powder for concentrate for solution for infusion.

The approval is for trastuzumab deruxtecan followed by a taxane, trastuzumab, and pertuzumab (THP) indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer.

In HER2-positive early breast cancer, treatment before surgery plays an important role in shaping the overall care pathway. It provides an opportunity to assess tumour response, guide post-surgical decisions and, where possible, improve longer-term outcomes.

However, with currently used neoadjuvant regimens, pathological complete response (pCR) is achieved in only 39% to 64% of patients, however, these regimens are associated with a range of acute and long-term toxicities. With no new therapies introduced in this setting for more than a decade, there remains a need for neoadjuvant options that can deliver stronger efficacy while reducing treatment burden. 

Trastuzumab deruxtecan is also approved in India for use in specified settings in metastatic HER2-positive breast cancer, including in combination with pertuzumab in the first-line setting, in HER2-low and HER2-ultralow metastatic breast cancer, in locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma after an anti-HER-2 based regimen, and in other unresectable or metastatic HER2-positive (IHC3+) solid tumours after prior systemic treatment where no satisfactory alternative treatment options exist.

This approval broadens the role of trastuzumab deruxtecan in India and adds a new option in the neoadjuvant treatment of HER2-positive early breast cancer.