CDSCO grants dual approval for Trastuzumab Deruxtecan

This CDSCO approval follows a prior trastuzumab-based regimen, providing a new avenue for treatment in this challenging disease landscape.

The Health Master

March 28, 2024

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CDSCO Central Drug Standard Control Organisation — CDSCO

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Last Updated on April 10, 2024 by The Health Master

CDSCO

AstraZeneca Pharma India has achieved a significant milestone with the recent approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, allowing the import, sale, and distribution of Trastuzumab deruxtecan lyophilised powder for concentrate for solution for infusion 100mg for two additional indications.

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1. Introduction

Trastuzumab deruxtecan, a groundbreaking treatment, has garnered attention in the medical community for its efficacy in combating HER2-positive cancers.

Initially approved by the Drug Controller General of India (DCGI) for HER2-positive breast cancer, its recent approval for expanded indications marks a pivotal moment in cancer treatment in India.

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2. CDSCO Approval for Additional Indications

HER2-Low Metastatic Breast Cancer

Trastuzumab deruxtecan now stands as a beacon of hope for patients battling HER2-low metastatic breast cancer.

This CDSCO approval extends its usage to adult patients with unresectable or metastatic HER2-low breast cancer who have undergone prior chemotherapy in the metastatic setting or experienced disease recurrence post-adjuvant chemotherapy completion.

Locally Advanced or Metastatic Gastric Cancer

In the realm of gastric cancer treatment, Trastuzumab deruxtecan offers promise to adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

This CDSCO approval follows a prior trastuzumab-based regimen, providing a new avenue for treatment in this challenging disease landscape.

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3. Understanding HER2-Low Breast Cancer

HER2-low breast cancer represents a subset of breast cancer patients with lower expression levels of HER2 protein.

While traditionally HER2-targeted therapies have focused on HER2-positive tumors, the emergence of Trastuzumab deruxtecan offers a tailored approach to address the needs of this specific patient population.

4. Mechanism of Action

Trastuzumab deruxtecan operates through a sophisticated mechanism of action, combining the targeting ability of trastuzumab with the cytotoxic payload of deruxtecan.

By specifically targeting HER2-expressing cancer cells, it delivers a potent cytotoxic payload, inducing cell death and impeding tumor growth.

5. Clinical Trials

Clinical trials have showcased the remarkable efficacy of Trastuzumab deruxtecan in HER2-positive cancers.

Studies have demonstrated significant improvements in progression-free survival and overall response rates compared to standard therapies, reaffirming its position as a frontrunner in cancer treatment.

6. Treatment Guidelines

Guidelines now recommend the inclusion of Trastuzumab deruxtecan in the treatment armamentarium for HER2-low metastatic breast cancer and HER2-positive gastric cancer.

Its approval expands treatment options, offering physicians a versatile tool to tailor therapy according to individual patient needs.

7. Side Effects and Safety

While Trastuzumab deruxtecan offers promising efficacy, it is essential to acknowledge potential side effects.

Common adverse reactions include nausea, fatigue, and neutropenia.

However, proactive management strategies can mitigate these effects, ensuring patients receive optimal care throughout treatment.

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