AstraZeneca Pharma India Limited has informed the Exchange about General Updates
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AstraZeneca Pharma India has received permission from CDSCO (Central Drugs Standard Control Organization) to import and distribute Acalabrutinib maleate 100mg tablets (brand: Calquence®) for an additional indication. The new approval allows the drug to be used in combination with Bendamustine and Rituximab (BR) for previously untreated mantle cell lymphoma (MCL) patients who are not eligible for autologous stem cell transplant. This expands the drug's therapeutic use in India and paves the way for marketing in this new indication, subject to related statutory approvals.
This approval expands Calquence®'s addressable patient population in India, potentially increasing revenue contribution from this drug as it targets a specific unmet medical need in mantle cell lymphoma treatment.