Erleada (apalutamid) dopuszczna w nieprzerzutowym CRPC

Erleada (apalutamid) dopuszczna w nieprzerzutowym CRPC

Nieprzeczytany postautor: bela71 » 15 lut 2018, 20:12

Apalutamid (ARN-509, JNJ-56021927, nazwa handlowa Erleada) dopuszczony przez FDA do stosowania w hormonoopornym raku prostaty bez przerzutów.


FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint


https://www.fda.gov/NewsEvents/Newsroom ... 596768.htm



FDA Approves Apalutamide for Nonmetastatic Castration-Resistant Prostate Cancer
The FDA has approved apalutamide (Erleada) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). The drug is now the first FDA-approved treatment in this setting.

The approval is based on the phase III SPARTAN trial in which apalutamide reduced the risk of metastasis or death by 72% in patients with nonmetastatic CRPC. The median metastasis-free survival (MFS) was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm (HR, 0.28; 95% CI, 0.23-0.35; P <.0001).

“The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public."

The SPARTAN trial evaluated the safety and efficacy of apalutamide versus placebo in 1207 patients with nonmetastatic CRPC and a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy. Nonmetastatic status was determined by a negative bone scan, as well as a negative CT of the pelvis, abdomen, chest, and brain.

Patients were required to have a PSA doubling time of ≤10 months, since “prior data has shown that these are the patients most at risk for developing metastases and death,” said Small.

Patients were randomized in a 2:1 ratio to 240 mg of apalutamide daily (n = 806) or placebo (n = 401). The average baseline PSA doubling time was less than 5 months in both arms. Patients who developed metastases were allowed to receive abiraterone acetate (Zytiga) plus prednisone, which Small noted is the standard of care in patients with metastatic CRPC.

Beyond the primary MFS endpoint, secondary endpoints included time to metastasis, progression-free survival, time to symptomatic progression, and overall survival (OS). For patients who developed metastases, the researchers also evaluated the time between randomization to first treatment for metastatic CRPC and subsequent progression (PFS2).

At a median follow-up of 20.3 months, 61% of the apalutamide arm remained on treatment compared with 30% of the placebo group. An interim OS analysis (24% of events) revealed a trend favoring apalutamide.


http://www.onclive.com/web-exclusives/f ... ate-cancer



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