FDA grants accelerated approval for J&J’s cancer drug Darzalex

According to Dr. Paul Richardson, the chief of the team that led the trails and also the director of clinical research at Dana-Farber Cancer Institute “Multiple myeloma is a highly complex disease and remains incurable, with nearly all patients relapsing or becoming resistant to therapy, With Darzalex, we have a promising new immunotherapy, which has shown pronounced efficacy as a single agent with an acceptable adverse event profile”.

The US Food and Drug Administration (FDA) has approved Janssen Biotech’s Darzalex (daratumumab) injection for intravenous infusion for the treatment of patients with multiple myeloma who have received at least three prior treatments. In addition, the drug may lead to lymphopenia, neutropenia, and leukopenia, as well as anemia and thrombocytopenia, FDA said. Darzalex is initially dosed once a week for two months, with this loading phase followed by maintenance treatment with monthly infusions.

Darzalex is a monoclonal antibody that’s created to help the body’s immune system fight cancer cells, the FDA said.

The most common side effects of the treatment included fatigue, nausea, back pain, fever and cough.

In a study involving 106 patients, tumors shrank or were not detectable any longer in 29 percent of the patients taking Darzalex and the benefit extended to about 7.4 months on an average. In the second study of 42 participants receiving Darzalex, 36% had a complete or partial reduction in their tumour burden.

Eventually, all patients become resistant to therapies that are presently available including Takeda’s Decade and Reclaimed from Colene.

Blood banks should be informed that patients are receiving Darzalex because the drug may interfere with certain tests that are done by blood banks (such as antibody screening) for patients who need a blood transfusion.

The approval comes well ahead of schedule as the FDA’s action date for the review was not until March 9 next year, and reflects the importance of the new drug for patients who have run out of other treatment options. This program only approves drugs those can treat a lethal condition showing clinical data that proves the effectiveness of the drug. Orphan drug designation provides incentives such as tax credits, user fee waivers and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.