The US FDA has recently granted Orphan Drug Designation to AstraZeneca’s Imfinzi (durvalumab) and tremelimumab, combination therapy for HCC.
Imfinzi, a monoclonal antibody, binds and inhibits the interaction of PD-L1 with PD-1 and CD80. The drug blocks tumour’s immune-evading mechanism and releases the inhibition of the immune response.
Hepatocellular cell carcinoma is the most common type of primary cell carcinoma, with a prevalence of 105,785 in 2017, and is expected to rise in coming years.
The recommendation came after the results from the Phase III trial HIMALAYA, which evaluated Imfinzi in combination with tremelimumab in patients suffering from unresectable, advanced HCC. The study is the first trial to test dual immune checkpoint blockade in the 1st line advanced HCC treatment.
Novartis has recently got approval from the EU for its secondary progressive multiple sclerosis (SPMS) drug, Mayzent.
The approval of the EU will make Mayzent the first and only orally indicated treatment for SPMS with active diseases demonstrated by relapses or imaging features of inflammatory activity.
The approval came after the results of the drug obtained during the randomised, double-blind, placebo-controlled Phase III EXPAND clinical trial, which evaluated the safety and efficacy in 1,651 SPMS patients from 31 countries.
Novartis gained approval from the USFDA in March last year for Mayzent for relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease, in adults. Moreover, the Australian Therapeutic Goods Administration (TGA) recommended its use from November onwards, and filings are in process in Switzerland, Japan, Canada and China.
Verrica Pharmaceuticals has announced the positive results of a study evaluating VP-102 for the treatment of molluscum contagiosum.
Tested in the pivotal Phase 3 CAMP trials, VP-102 (cantharidin 0.7% topical solution), is the company’s lead product. The results showed complete elimination of lesions in all body regions.
The disease significantly affects the head, neck, abdomen, back, buttocks, and other body parts as well.
If approved, VP-102 would form a better treatment option to even treat sensitive zones such as groin of the body.