Friday, April 1, 2022

ADC Therapeutics scores FDA approval for anti-CD19 blood cancer med Zynlonta

Multiple new CAR-T medicines against diffuse large B-cell lymphoma (DLBCL) have hit the market in recent years, improving prospects for patients and extending the array of available options for doctors. Now, with an FDA approval Friday afternoon, ADC Therapeutics is getting ready to launch the first single-agent CD19-targeted antibody drug conjugate therapy against the disease.

ADC Therapeutics scored an FDA nod for Zynlonta, formerly known as loncastuximab, as a solo treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma after two prior lines of therapy. 

The FDA endorsed the drug based on data from a multinational phase 2 trial called Lotis-2 in patients with r/r DLBCL after two lines of therapy. The drug turned in an overall response rate of 48.3%, and for those who responded, the median duration of response was 10.3 months. More than 24% of patients experienced a complete response.

The med scored an accelerated approval, meaning the company may have to demonstrate the med’s efficacy in a confirmatory trial to retain the licensure.

RELATED: ADC gets priority review for anti-CD19 blood cancer drug

ADC filed the data with the FDA in September and scored a priority review for the application in November.

Zynlonta joins a series of DLBCL drugs to score approvals in recent years, including CAR-T meds from Novartis, Gilead Sciences and Bristol Myers Squibb. Other meds eying the indication include MorphoSys and Incyte’s CD19 antibody Monjuvi and Roche’s anti-CD79b ADC Polivy.

Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...