publication date: Jul. 21, 2017

Drugs and Targets

FDA approves treatment to reduce risk of breast cancer returning

FDA approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.

The FDA granted the approval of Nerlynx to Puma Biotechnology Inc.

Nerlynx is a kinase inhibitor that works by blocking several enzymes that promote cell growth. The safety and efficacy of Nerlynx were studied in a randomized trial of 2,840 patients with early-stage, HER2-positive breast cancer who completed treatment with trastuzumab within the previous two years.

The study measured the amount of time after the start of the trial that it took for the cancer to come back or for death to occur from any cause (invasive, disease-free survival).

After two years, 94.2 percent of patients treated with Nerlynx had not experienced cancer recurrence or death, compared with 91.9 percent of patients receiving placebo.

Common side effects of Nerlynx include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, swollen and sore mouth (stomatitis), decreased appetite, muscle spasms, indigestion (dyspepsia), liver damage (AST or ALT enzyme increase), nail disorder, dry skin, abdominal swelling (distention), weight loss and urinary tract infection.


FDA accepts for priority review BMS application for dasatinib in children with CP Ph+ CML

Bristol-Myers Squibb Co. said the FDA accepted its supplemental New Drug Application to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel.

The application has an action date of Nov. 9.

The sNDA includes data from CA180-226 (NCT00777036), an ongoing phase II, open-label, non-randomized trial studying Sprycel in pediatric patients with CP-CML that are resistant to or intolerant of imatinib and in pediatric patients newly diagnosed with CP-CML.

The efficacy endpoints included cumulative major cytogenetic response rate among imatinib-resistant or intolerant patients and cumulative complete cytogenetic response rate in newly diagnosed patients.

Additional efficacy measures were time to and duration of response, progression-free survival, overall survival and major molecular response. Safety was also assessed.

Sprycel first received FDA approval in 2006 for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase who are resistant or intolerant to prior therapy including imatinib.

At that time, Sprycel was also approved for adults with Ph+ acute lymphoblastic leukemia who are resistant or intolerant to prior therapy. Sprycel is approved and marketed worldwide for these indications in more than 60 countries.

Sprycel is also an FDA-approved treatment for adults with newly diagnosed CP Ph+ CML (since October 2010). Sprycel received accelerated FDA approval for this indication. This indication is approved in more than 50 countries.

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