AstraZeneca Pharma

阿斯利康制药

on Tuesday said it has received approval from the national drug regulator to market a cancer treatment drug in the country.

周二表示，已获得国家药品监管机构的批准，可以在该国市场上销售一种癌症治疗药物。

The company has received approval from the Central Drugs Standard Control Organisation (

公司已获得中央药品标准控制组织的批准 (

CDSCO

中央药品标准控制组织

) to import, market, and distribute

）进口、营销和分销

Trastuzumab Deruxtecan

德曲妥珠单抗

for an additional indication in India, the drug firm said in a statement.

该公司在一份声明中表示，这是针对印度的另一个适应症。

With this approval, Trastuzumab Deruxtecan is now indicated for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumours, who have received prior systemic therapy and have no satisfactory alternative treatment options, it added.

该批准通过后，Trastuzumab Deruxtecan 现适用于治疗不可切除或转移性 HER2 阳性实体瘤的成年患者，这些患者曾接受过先前的系统治疗且无其他满意的替代治疗方案。

This marks the first and only antibody drug conjugate in India with a tumour-agnostic indication, representing a significant advancement in precision oncology, the company said.

该公司表示，这标志着印度首个也是唯一一个具有肿瘤不可知适应症的抗体药物偶联物，代表着精准肿瘤学的重大进展。

'This milestone reflects our unwavering commitment to patient-centricity, scientific excellence, and equitable access to breakthrough therapies. By bringing Trastuzumab Deruxtecan to patients in India with HER2-positive solid tumours, we take a significant step forward in addressing unmet medical needs and transforming cancer care,' AstraZeneca Pharma India Country President & MD Praveen Rao Akkinepally said..

“这一里程碑反映了我们对以患者为中心、科学卓越以及公平获得突破性疗法的坚定承诺。通过将Trastuzumab Deruxtecan带给印度的HER2阳性实体瘤患者，我们在解决未满足的医疗需求和变革癌症治疗方面迈出了重要一步，”阿斯利康制药印度国家总裁兼董事总经理普拉文·拉奥·阿基内帕利表示。

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Trastuzumab Deruxtecan is already approved in India for the treatment of metastatic breast cancer (HER2-positive, HER2-low, and HER2-ultralow) and locally advanced or metastatic gastric cancer.

Trastuzumab Deruxtecan 已在印度获批用于治疗转移性乳腺癌（HER2阳性、HER2低表达和HER2超低表达）以及局部晚期或转移性胃癌。

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The tumour-agnostic approval further broadens its potential to benefit patients across a range of advanced HER2-positive cancers.

肿瘤不可知论的批准进一步扩大了其潜在的益处，可惠及一系列晚期HER2阳性癌症患者。

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