AstraZeneca and Acerta Pharma say European advisors have recommended orphan drug designation for cancer drug acalabrutinib in three indications.
The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has adopted three positive opinions recommending the breakthrough badge for the treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma, mantle cell lymphoma and lymphoplasmacytic lymphoma (Waldenström’s macroglobulinaemia, MG).
Back in December AstraZeneca announced that is was taking a majority equity investment in the privately held US/Dutch clinical stage biopharma in a deal valued at some $4 billion.
Sean Bohen, AZ’ chief medical officer, said the COMP’s decision now reinforces the strategic rationale for that investment, “demonstrating clear progress in developing a potential best-in-class medicine that could transform treatment for patients across a range of blood cancers”.
In addition to ongoing trials in these indications, acalabrutinib is also currently being tested in Phase I/II trials in monotherapy as well as in combination with immunotherapy or chemotherapies in a range of other blood cancers and solid tumours.
The drug is a BTK inhibitor with a mode of action similar to AbbVie/Johnson & Johnson’s blood cancer drug Imbruvica (ibrutinib), which is widely expected to rake in peak sales in excess of $5 billion.