CDSCO Grants AstraZeneca Approval to Import Lynparza for Cancer Treatment

AstraZeneca Pharma India Ltd has achieved a significant milestone by receiving approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute its cancer treatment drug Olaparib, branded as Lynparza, in India. This development is set to expand the treatment options available for patients battling advanced endometrial cancer.

Details of Lynparza Approval

The CDSCO has granted permission for the import and distribution of Lynparza in film-coated tablet form. The drug will be available in 100 mg and 150 mg dosages for sale in India. This approval marks a critical step in introducing this innovative treatment to the Indian market.

Treatment Applications of Lynparza

Lynparza, when combined with Durvalumab, is specifically indicated for the maintenance treatment of adult patients with advanced or recurrent endometrial cancer. It is particularly beneficial for patients whose disease has not progressed following first-line treatment with Durvalumab and platinum-based chemotherapy. This combination therapy offers a promising new option for managing this challenging condition.

Plans for Lynparza’s Launch in India

With the CDSCO’s approval, AstraZeneca Pharma India is now poised to launch Lynparza in the Indian market. The drug’s availability is expected to significantly enhance the therapeutic landscape for advanced endometrial cancer patients in the country.

Additional Approval for Breztri Aerosphere

In addition to Lynparza, AstraZeneca Pharma India recently received import and market permission for its inhalation preparation, Breztri Aerosphere. This medication is designed for the treatment of chronic obstructive pulmonary disease (COPD). The company has announced plans to launch Breztri Aerosphere in January 2025, further diversifying its product offerings in the respiratory therapeutic area.

AstraZeneca Pharma’s Expanding Portfolio

AstraZeneca Pharma India, the Indian arm of the British-Swedish pharmaceutical giant, continues to expand its footprint across various therapeutic segments, including oncology, cardiovascular, and respiratory diseases. The company gained international recognition for its role in developing the Oxford–AstraZeneca Covid-19 vaccine, cementing its position as a global leader in pharmaceutical innovation.

Market Reaction to the Announcement

Following the announcement of the CDSCO approval for Lynparza and Breztri Aerosphere, AstraZeneca Pharma India’s shares witnessed a notable surge. The stock rose by 2% to an intraday high of ₹6,587 per share on the Bombay Stock Exchange (BSE). Although the stock pared some gains, it closed at ₹6,450, reflecting investor optimism about the company’s growth prospects.

Looking Ahead

The approval and impending launch of Lynparza and Breztri Aerosphere highlight AstraZeneca Pharma India’s commitment to bringing cutting-edge treatments to the Indian market. By expanding its oncology and respiratory care portfolios, the company is set to make a significant impact on patient care in India, addressing unmet medical needs in critical therapeutic areas.