AstraZeneca Pharma India Gets CDSCO Approval for Lynparza Cancer Drug

AstraZeneca Pharma India Ltd. has secured approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute its cancer treatment drug, Lynparza (Olaparib), in India. This regulatory approval marks a major development in the company’s oncology portfolio, offering hope for patients with advanced endometrial cancer.

Details of the Approval

The approval allows the import and sale of Lynparza in 100 mg and 150 mg film-coated tablet forms. Specifically, Lynparza, in combination with Durvalumab, is indicated for the maintenance treatment of adult patients with advanced or recurrent endometrial cancer. The combination is suitable for those whose disease has not progressed after first-line treatment with Durvalumab and platinum-based chemotherapy.

The company also said that this approval will facilitate the launch of Lynparza for this additional indication in India, pending further statutory clearances.

Broader Portfolio Expansion

In addition to Lynparza, AstraZeneca recently received approval to market Breztri Aerosphere, a treatment for chronic obstructive pulmonary disease (COPD). This product is set to launch in India by January 2025, expanding the company’s presence in the respiratory segment.

Market Performance & Updates

Following the announcement, AstraZeneca Pharma India’s shares rose by 1.10% today, reaching Rs 6,523.95 and otherwise the stock has risen 15.56% year-to-date and 37.50% over the past year.

In the second quarter ending September 30, 2024, AstraZeneca Pharma India reported a 27% year-on-year decline in net profit to Rs 38 crore, compared to Rs 52 crore in the same period last year. Despite this, revenue surged 31% to Rs 408 crore, driven by a good operational performance.

The CDSCO’s approval of Lynparza strengthens AstraZeneca Pharma India’s oncology offerings, addressing a gap in advanced cancer care. Coupled with Breztri Aerosphere’s January 2025 launch, AstraZeneca is strengthening its presence across oncology and respiratory, driving Rs 408 crore in Q2FY25 revenue.

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