The US Food and Drug Administration (FDA) has approved AstraZeneca PLC's (LSE:AZN) Calquence (acalabrutinib), in combination with bendamustine and rituximab, as a first-line treatment for adults with previously untreated mantle cell lymphoma (MCL) who cannot undergo stem cell transplantation.
This approval marks the first time a Bruton’s tyrosine kinase (BTK) inhibitor has been authorised in the US for newly diagnosed MCL patients.
MCL is a rare and aggressive type of non-Hodgkin lymphoma, a cancer affecting the lymphatic system.
It typically presents at an advanced stage, with symptoms such as swollen lymph nodes, fever, and fatigue. Current estimates suggest that over 21,000 people in major global markets, including the US and UK, live with MCL.
BTK inhibitors, such as Calquence, target a specific protein (Bruton’s tyrosine kinase) crucial for the survival and proliferation of certain cancer cells. By blocking this protein, BTK inhibitors disrupt cancer cell growth and improve patient outcomes.
The ECHO Phase III trial, which underpins this approval, demonstrated that Calquence combined with bendamustine (a chemotherapy drug) and rituximab (a targeted immunotherapy) significantly improved progression-free survival by over 16 months compared to chemoimmunotherapy alone.
This means patients experienced a longer period without their cancer worsening.
Dr Michael Wang, lead investigator of the trial, called the combination a “new standard of care” for elderly or vulnerable patients. With this decision, Calquence’s previous accelerated approval for relapsed MCL has been converted to full approval, offering new hope for those living with this challenging disease.