AstraZeneca Pharma India gets DCGI nod for Calquence-Acalabrutinib 100mg capsules

India: AstraZeneca Pharma India Limited has received Import and Market permission in Form CT-20 (Marketing Authorization- Additional Indication) from the Drugs Controller General of India for Acalabrutinib 100mg capsules (Calquence®).

The receipt of this Import and Market permission paves way for the launch of Acalabrutinib 100mg capsules (Calquence®) in India, subject to the receipt of related statutory approvals and licenses.

Acalabrutinib 100mg capsules are indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL)/ small lymphocytic lymphoma (SLL).

CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer. It is not known if CALQUENCE is safe and effective in children. CALQUENCE targets and helps block a protein, called BTK, that contributes to cancer cell growth and survival. It is a type of medicine called a Bruton tyrosine kinase inhibitor, or BTKi.

In 2019, the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).1 The US approval was granted under the FDA's Real-Time Oncology Review and newly established Project Orbis programmes.

The approval is based on positive results from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both 1st-line and relapsed or refractory CLL. Across both trials, the safety and tolerability of Calquence were consistent with its established profile

AstraZeneca is a global biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

AstraZeneca Pharma India Limited (AstraZeneca India) was established in 1979. It is headquartered at Bengaluru, Karnataka. 

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