US regulators are undertaking a speedy review of AstraZeneca’s application to market durvalumab for patients with bladder cancer.
In this setting, the PD-L1 human monoclonal antibody (mAb) is being targeted towards patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after one standard platinum‑based regimen.
Earlier this year, the immunotherapy received a breakthrough designation for bladder cancer on the basis of early clinical data from a Phase I trial (Study 1108) in patients with advanced metastatic forms of the disease.
“The BLA acceptance of durvalumab in urothelial cancer is an important milestone for patients who still face considerable unmet medical need in this area,” noted Sean Bohen, AZ’ chief medical officer.
Given the priority review designation, a decision by US Food and Drug Administration is expected second quarter of 2017.
If approved, it would be AZ’s first immunotherapy to make it to market, although it would face competition from established immuno-oncology drugs such as Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab).
The drug is also being investigated in a number of other cancers, including lung, head and neck, liver, and blood cancers.
Lilly, AZ Alzheimer’s pact
Meanwhile, AZ and Eli Lilly announced a new partnership to co-develop a potential new therapy for Alzheimer’s disease focused on the amyloid beta pathway.
The companies will work together on MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42) which is currently in Phase I trials as a potential disease-modifying treatment for the condition.
The build-up of plaques in the brain containing the peptide amyloid-beta (Aβ) is a key characteristic of AD. MEDI1814 binds selectively to Aβ42 and dose-dependently reduces levels of the peptide, potentially slowing the disease’s progression.
The agreement follows the firms’ existing collaboration relating to AZD3293, a BACE inhibitor currently in two pivotal Phase III trials.
“MEDI1814 has a unique mechanism among antibodies in clinical development and could provide a distinct approach to treating Alzheimer’s disease,” said Mene Pangalos, executive vice president, IMED Biotech Unit and Business Development, at AZ.
Further details of the deal were not disclosed.
