- The Food and Drug Administration approved AstraZeneca's Calquence for treating patients with chronic lymphocytic leukemia (CLL), allowing it to take on AbbVie and Johnson & Johnson's Imbruvica, a $5.6 billion-a-year seller.
- AstraZeneca's oncology business chief David Fredrickson said recently the company believes about half of all prescriptions in the third quarter of 2019 were in CLL thanks to its addition to oncology treatment guidelines. AstraZeneca's sales and marketing team could not promote the drug in CLL until it received FDA approval.
- Leerink analyst Andrew Berens forecasted Calquence sales of $895 million in 2022, largely due to the CLL launch.
AbbVie and Johnson & Johnson's Imbruvica (ibrutinib) was the only drug in a class called Bruton tyrosine kinase inhibitors, until two years ago. On the market since 2013, Imbruvica has grown into a multibillion-dollar product, expanding from the first setting of mantle cell lymphoma, a rare cancer, into CLL and three other indications.
AstraZeneca has employed the same tactic, first achieving the mantle cell lymphoma approval for Calquence (acalabrutinib) and, on Thursday, CLL. Both companies are being closely chased by BeiGene, which received a mantle cell lymphoma nod last week for Brukinsa (zanubrutinib).
Calquence's CLL approval was based on two clinical trials that compared the kinase inhibitor against Roche's Gazyva (obinutuzumab) and against combination therapies with Roche's Rituxan (rituximab) as a backbone. Against Gazyva, Calquence monotherapy reduced the risk of disease progression by 80% and against Rituxan combinations it was 69%.
Leerink's Berens characterized those data as "competitive" against Imbruvica.
He added that Calquence may prove attractive to patients and oncologists because it has fewer side effects. About 30% to 40% of Imbruvica patients have trouble tolerating the drug because of bleeding issues or irregular heartbeats, which forces them to stop taking it even though they are in remission. Calquence had lower rates of those side effects.
AstraZeneca said Calquence's sales of $108 million were aided by pre-approval use in CLL. Thanks to the new approval, Berens forecasts annual sales growth of 29% through 2030, which would make it a blockbuster by 2023.
Sales could be helped along by additional clinical studies in B-cell lymphomas and multiple myeloma. Among the combinations being tested are Calquence and Keytruda (pembrolizumab) broadly in blood cancers, and with another kinase inhibitor called ACP-319 in B-cell malignancies.