FDA Approves Calquence for Mantle Cell Lymphoma

Reuters

CALQUENCE (acalabrutinib), was granted accelerated approval by the US Food and Drug Administration (FDA).

Calquence functions by blocking the BTK enzyme which is responsible for multiplication and spreading of the cancer.

Avella (Arizona-based speciality pharmacy) announced that it has been selected by AstraZeneca to distribute CALQUENCE (acalabrutinib), a Bruton tyrosine kinase (BTK) inhibitor indicated for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Calquence (acalabrutinib) is expected to take market share from AbbVie and Janssen's Imbruvica, which is now a well established second line treatment in MCL and first line treatment in chronic lymphocytic leukaemia (CLL).

When Astrazeneca acquired the treatment from Acerta Pharma in 2015, it forecast sales of more than $5 billion a year.

The most common adverse events (AEs) of any grade were anemia (46 percent), thrombocytopenia (44 percent), headache (39 percent), neutropenia (36 percent), diarrhea (31 percent), fatigue (28 percent), myalgia (21 percent) and bruising (21 percent), which is a known class effect for BTK inhibition.

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Continued approval for this may be dependent on the verification and description of clinical benefit in confirmatory trials.

Under the Accelerated Approval pathway, the FDA may approve drugs which exhibit clinical benefit to patients with severe conditions with an unmet medical need.

The accelerated approval was based on data from from the single-arm trial LY-004 (n=124) that evaluated the overall response rate (ORR) among adults with mantle cell lymphoma who received ≥1 prior therapy; median follow-up was 15.2 months. "Furthermore, today's approval demonstrates our commitment to scientific leadership in Oncology and reinforces our progress towards returning to growth", said Chief Executive Officer Pascal Soriot.

The phase 3 ACE-LY-308 clinical trial is now evaluating Calquence in combination with bendamustine and Rituxan (rituximab) (BR) versus placebo plus BR for patients with untreated MCL.

It is also being studied as a monotherapy and in combination trials for solid tumours. The trial showed that 81% of patients had a complete or partial response, out of which 40% showed complete response.

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