- Janssen, a unit of Johnson & Johnson, was granted conditional approval to market its multiple myeloma drug Darazalex in Europe, building on momentum from an approval in the U.S. late last year.
- The European Commission approved Darzalex for second-line treatment of the blood cancer in patients with relapsed and refractory forms of the disease. The accelerated approval will require further study of the drug's benefits.
- Darzalex binds to a surface molecule typically expressed by multiple myeloma cells, thereby triggering the patient's immune system to attack and kill the cancer.
Darzalex is one of four new multiple myeloma meds on the U.S. market. Along with Darzalex, Novartis' Farydak, Takeda's Ninlaro, and Bristol-Myer Squibb's Empliciti have all won approval within the past year or so.
The wave of new drugs is a promising development, as nearly 30% of patients diagnosed with the disease die within one year of diagnosis. Five-year survival rates approach 50%, according to Janssen.
In a combined analysis of a phase 1/2 study and a phase 2 study, treatment with Darzalex led to a median overall survival rate of 20 months in heavily pre-treated patients. Overall response rates were 31%, with "clinically manageable" side effects, the company said.
While effective to varying degrees in treating the cancer, Darzalex and the other new drugs are pricey. A new assessment from the Institute for Clinical and Economic Review (ICER) (which included Amgen's Kyprolis) recommended discounts of between 32% to 94% from the drugs' list prices.
"Achieving levels of value more closely aligned with patient benefit would require substantial discounts from the list price in many cases, and in other cases, there is no realistic price for the newest agents that would achieve these thresholds," ICER said in a release.
Drugmakers have pushed back against ICER's analysis, however. Amgen, for example, publicly questioned the methodology ICER relied on for its assessment.
A meeting is scheduled for later this week to review ICER's findings.