AstraZeneca Gains Approval for Calquence in Treating Mantle Cell Lymphoma
AstraZeneca Pharma India Limited has received significant regulatory permission for the continued sale and distribution of a key oncology drug. The company confirmed that it obtained clearance from the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India, for an additional indication of its product.The approval covers Acalabrutinib maleate tablets 100 mg, which is marketed under the brand name Calquence ®. This development significantly expands the therapeutic scope of the medicine within India.
New Indication for Mantle Cell Lymphoma
The new indication allows for the use of Acalabrutinib in combination with Bendamustine and Rituximab (BR). This combination treatment is specifically designated for adult patients battling previously untreated mantle cell lymphoma (MCL) who do not qualify for autologous stem cell transplant (ASCT).The receipt of this official permission paves the way for the marketing of Acalabrutinib maleate tablets 100 mg (Calquence ®) for this specified additional indication in India, pending the fulfillment of any necessary related statutory approvals.
ASTRAZEN Stock Price Movement
AstraZeneca Pharma India Limited shares today slipped by 0.38% to settle at ₹8609.50. The stock finished the session with a relatively low volume of 4,397 shares.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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