(Reuters) – AstraZeneca Plc said on Thursday its blood cancer drug met the main goal of a final stage trial, taking the treatment one step closer to a marketing approval as the drugmaker seeks to bolster its oncology portfolio.
In its second late-stage trial success in a month, the drug showed meaningful improvement in patients with chronic lymphocytic leukemia when compared with a chemotherapy-based treatment, the company said.
The drug, Calquence, is a cornerstone product for AstraZeneca in haematology and its accelerated U.S. approval in 2017 marked its first entry into blood cancer treatment.
“The positive results from both the … trials will serve as the foundation for regulatory submissions later this year,” said R&D José Baselga, executive vice president of the company’s oncology division.
The drug, which is already approved by the U.S. drug regulator to treat a rare type of blood cancer, met the primary endpoint in a trial in May testing the drug in comparison with available treatment.
AstraZeneca acquired the drug, also known as acalabrutinib, when it bought a majority stake in Acerta Pharma in 2015.
Calquence is currently approved for treating adults with relapsed or refractory mantle cell lymphoma in the United States, Brazil, UAE and Qatar, and is being developed for the treatment of chronic lymphocytic leukemia and other blood cancers.
The company’s shares were up 0.8% at 6005 pence in early trading on the London Stock Exchange.
Reporting by Sangameswaran S in Bengaluru; Editing by Saumyadeb Chakrabarty