Regulatory Affairs

FDA accepts BMS’ sNDA to review Sprycel in Philadelphia CP CML

PBR Staff Writer Published 11 July 2017

The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) submitted by Bristol-Myers Squibb (BMS) for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase (CP) chronic myeloid leukemia (CML).

FDA has also accepted sNDA for powder for oral suspension (PFOS) formulation of Sprycel.

The sNDA has been submitted based on data from CA180-226, which is an ongoing phase 2, open-label and non-randomized trial assessing Sprycel in pediatric patients with CP-CML that are resistant to or intolerant of imatinib and in pediatric patients newly diagnosed with CP-CML.

According to BMS, the efficacy endpoints comprise of cumulative major cytogenetic response rate among imatinib-resistant or intolerant patients, as well as cumulative complete cytogenetic response rate in newly diagnosed patients.

Additional efficacy measures include time to and duration of response, progression-free survival, overall survival and major molecular response.

In 2006, Sprycel first secured FDA approval to treat adults with Philadelphia chromosome-positive (Ph+) CML in CP who are resistant or intolerant to prior therapy including imatinib.

The treatment also secured approval for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to prior therapy. It is available in around 60 countries with these indications.

BMS chief commercial officer and executive vice president Murdo Gordon said: “Today's news reinforces our commitment to addressing the unique and often unmet needs of pediatric oncology patients, including children with newly diagnosed and imatinib intolerant or resistant CML.

“Sprycel also has the potential to be the first drug in its class approved for pediatric use with an oral solution.”

Separately, BMS and Exelis have commenced the phase 3 CheckMate 9ER trial to evaluate Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) tablets, or Opdivo and Yervoy (ipilimumab) in combination with Cabometyx versus sunitinib in patients with previously untreated, advanced or metastatic renal cell carcinoma (RCC).

The progression-free survival (PFS) is the primary endpoint of the trial.

Image: BMS’ research campus in Princeton, New Jersey. Photo: courtesy of Coolcaesar