- Johnson & Johnson and its development partner Genmab were granted another breakthrough designation for their multiple myeloma drug Darzalex, this time for second-line treatment of the blood cancer, the companies said this week.
- Darzalex was approved last November by the Food and Drug Administration for use in heavily pretreated or double refractory multiple myeloma patients. A breakthrough designation indicates that initial evidence suggests a drug may offer substantial improvements over existing treatments and unlocks closer consultation with the FDA.
- Winning second-line approval for multiple myeloma would help Darzalex compete with other treatments already on the market, such as Celgene's Revlimid or newer drugs like Takeda's Ninlaro and Bristol-Myers Squibb's Empliciti. A breakthrough designation does not, however, guarantee approval.
Despite an array of treatment options multiple myeloma, there is still a need for new treatments to use when others have failed. Roughly 26,850 people will be diagnosed with multiple myeloma this year and 11,240 will die, according to the National Cancer Institute.
Darzalex's second breakthrough designation was based on date from two phase 3 trials which compared the drug in combination with either Takeda's Velcade or Celgene's Revlimid to those two treatments by themselves plus chemotherapy.
Original approval followed results which showed treatment with Darzalex led to a 36% response rate in patients who had become resistant to other treatments.
If approved for second-line use, Darzalex might be used in combination either Velcade or Revlimid, FierceBiotech notes. Although such a combination would likely improve patient outcomes, all three drugs are expensive—putting pressure on payers.
Darzalex is one of four new multiple myeloma meds on the U.S. market. Novartis' Farydak, Takeda's Ninlaro and Bristol-Myer Squibb's Empliciti have all won approval within the past year and a half.
Janssen pulled in nearly $102 million in first quarter sales of Darzalex (as reported by Genmab, which receives royalty revenues from Janssen).