Cancer drug: AstraZeneca Pharma India bags CSDCO permission to import Lynparza

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-11-26 10:24 GMT   |   Update On 2024-11-26 10:24 GMT
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Bangalore: AstraZeneca Pharma India Limited has received permission to import for sale and distribution in Form CT-20 from the Central Drugs Standard Control Organisation (CDSCO),  Directorate General of Health Services, Government of India for the additional indication of Olaparib film-coated Tablets 100 mg & 150 mg (Lynparza).

Through this approval, Olaparib in combination with Durvalumab is indicated for the maintenance treatment of adult patients with advanced or recurrent endometrial cancer whose disease has not progressed on first-line treatment with Durvalumab in combination with platinum-based chemotherapy.

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The receipt of this permission paves way for the launch of Olaparib film-coated Tablets 100 mg & 150 mg (Lynparza) in India for the above specified additional indication, subject to the receipt of related statutory approvals, if any.

Read also: AstraZeneca Tagrisso recommended for approval in EU by CHMP for patients with unresectable EGFR mutated lung cancer

Medical dialogues team had earlier reported that 
the company had also received permission to import for sale and distribution of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India for an additional indication, subject to the receipt of related statutory approvals, if any. 
Durvalumab in combination with chemotherapy as neoadjuvant treatment, followed by Durvalumab as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Established in 1979, the Company is headquartered at Bengaluru, Karnataka in India and has a workforce of over 800 employees across the country.

Read also: CDSCO panel Approves AstraZeneca's Protocol Amendment proposal for Datopotamab Deruxtecan study



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