AstraZeneca Pharma Secures Approval for Cancer Drug Lynparza Distribution in India

AstraZeneca Pharma India has announced regulatory approval to import and distribute Olaparib film-coated tablets (Lynparza) in 100 mg and 150 mg doses for a new therapeutic indication. The Central Drugs Standard Control Organisation (CDSCO) approved its use in combination with Durvalumab for maintenance treatment of advanced or recurrent endometrial cancer in adults whose disease has not progressed following first-line platinum-based chemotherapy.

This marks a significant development for AstraZeneca Pharma India, paving the way to introduce Olaparib for this expanded indication, subject to further regulatory clearances.

Olaparib, a groundbreaking PARP (poly ADP-ribose polymerase) inhibitor, received regulatory approval in December 2014 as a single-agent therapy from both the European Medicines Agency (EMA) in the European Union and the U.S. Food and Drug Administration (FDA).

The drug marked a major advancement in the treatment of certain cancers, particularly ovarian cancer associated with BRCA mutations. By targeting DNA repair pathways, olaparib offers a tailored approach, paving the way for precision oncology treatments. Its dual approval from prominent regulatory authorities underscored its global significance and positioned it as a cornerstone therapy in targeted cancer treatment.

Market and Business Impact

Following the announcement, the company’s shares rose by 1.98% during intraday trading on Tuesday, hitting a high of ₹6,583.65.

As the Indian subsidiary of the British-Swedish pharmaceutical leader, AstraZeneca Pharma operates in diverse therapeutic areas, including oncology, cardiovascular health, and respiratory conditions. Globally renowned for its contribution to the Oxford–AstraZeneca COVID-19 vaccine, the company continues to bolster its oncology portfolio with this new approval.

Financial Snapshot

Despite reporting a 27% year-on-year decline in net profit for the quarter ending September 30, 2024 (₹38 crore compared to ₹52 crore the previous year), AstraZeneca Pharma India posted a significant revenue increase. Revenue from operations surged to ₹408 crore from ₹311 crore, underscoring robust operational performance amid reduced profitability.

The addition of Olaparib for advanced endometrial cancer strengthens AstraZeneca Pharma India’s standing in oncology, promising better treatment options and potentially broadening its market presence.

(Input from various sources)

(Rehash/Josna Lewis/MSM)