Bristol Sprycel For Gleevec-Resistant Leukemia To Get Committee Review At June A

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Could Dasatinib be called " Sprycel? " - See news release below:

Bristol Sprycel For Gleevec-Resistant Leukemia To Get Committee

Review At June ASCO Meeting

FDA will take its Oncologic Drugs Advisory Committee on the road to

review Bristol-Myers Squibb's Sprycel (dasatinib) for the treatment

of resistant leukemias.

The meeting will take place on June 2 in Atlanta, Ga. on the first

day of the American Society for Clinical Oncology annual meeting.

The ASCO meeting runs June 2-6. Many of the committee members and

FDA oncology reviewers regularly attend the meeting, as do Bristol

representatives.

FDA will give the committee members a break, as they are likely to

have time constraints during the ASCO meeting; the agency is only

dedicating a half-day to the review, from 10 a.m. to 2 p.m.

Bristol is seeking accelerated approval for dasatinib for

the " treatment of adults with chronic, accelerated, or blast phase

chronic myeloid leukemia with resistance or intolerance to prior

therapy, including imatinib " (Novartis' Gleevec).

The company is also seeking an indication for " treatment of adults

with Philadelphia chromosome-positive acute lymphoblastic leukemia,

and lymphoid blast chronic myeloid leukemia with resistance or

intolerance to prior therapy. "

Bristol submitted the NDA for Sprycel on Dec. 28. FDA is giving the

application a priority review, which would give the product a June

28. user fee deadline.

The submission is primarily based on Phase II data from 1,000

Gleevec-resistant or intolerant patient with CML in various phases

of disease.

According to data presented at the American Society for Hematology

in December, 32% of the 74 patients with myeloid blast phase had a

major hematologic response with dasatinib and 24% of patients

experienced a complete hematologic response.

In 107 accelerated phase patients, dasatinib showed a 59% major

hematologic response rate with 33% of patients experiencing a

complete hematologic response.

The response was even higher in chronic phase patients who were

intolerant or resistant to Gleevec. Among 59 intolerant patients,

97% had a complete hematologic response. The response rate for 127

resistant chronic phase patients was 87%.

Complete cytogenetic response rates for the myeloid blast and

accelerated phase patients were in the 30% range, while 22% of

chronic phase patients resistant to imatinib had a complete

cytogenetic response; 56% of intolerant chronic phase patients had a

complete cytogenetic response.

The advisory committee will have to determine if the Phase II data

on hematologic and cytogenetic responses are enough to predict a

clinical benefit for dasatinib, such as prolonged survival in CML

patients.

Bristol estimates that 15%-20% of patients treated for CML do not

achieve major cytogenetic responses to Gleevec within the first 12

months and 5%-10% develop resistance.

Dasatinib is an oral multi-target kinase inhibitor, which, Bristol

reports, has a pre-clinical potency greater than imatinib.