- The Committee for Medicinal Products for Human Use (CHMP) is officially recommending that the European Medicine Agency (EMA) approve Janssen-Cilag's Imbruvica (ibrutinib) and Gilead's Zydelig (idelalisib) for the treatment of rare blood cancers.
- Both Imbruvica and Zydelig behave different from other currently-approved blood cancer medications and have been approved for treating chronic lymphocytic leukemia (CLL).
- Imbruvica and Zydelig have already been approved by the FDA for CLL and other blood cancer-related indications.
CMHP is recommending both Imbruvica and Zydelig for treatment of CLL in adults who have already received prior therapy or who have a specific genetic mutation that makes it impossible for them to receive chemoimmunotherapy. In addition, Imbruvica is being recommended for approval as a treatment for adults with mantle cell lymphoma (MCL), while Zydelig is also being recommended for treatment of refractory follicular lymphoma.
Zydelig received FDA approval earlier this month, while Imbruvica was approved by the FDA in February. Although CLL is rare, it represents 35% of all cases of leukemia. Patients with the disease often relapse even when their initial response to treatment is positive. Five-year survival rates for men and women with CLL is 44% and 52%, respetively. Pushing second-line treatment options such as Zydelig and Imbruvica is meant to buoy those numbers.
As BioPharma Dive has previously reported, Zydelig represents Gilead's first major foray into the cancer drug arena. Analysts have estimated that the drug's sales could pass the $1 billion mark despite competitive pressure from Johnson & Johnson.