FDA Grants Priority Review to VELCADE(R) (Bortezomib) for Injection for Treatment of Relapsed Mantle Cell Lymphoma
- Acceptance of application marks another step forward in the expansion of VELCADE -
CAMBRIDGE, Mass., Aug. 9 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that the U.S. Food and
Drug Administration (FDA) granted Priority Review designation to its
supplemental new drug application (sNDA) for VELCADE for the treatment of
relapsed mantle cell lymphoma (MCL), an aggressive, incurable subtype of
non-Hodgkin's lymphoma (NHL) for which there is no current standard of care.
Priority Review is granted to a pharmaceutical compound that addresses an
unmet medical need and would be a significant improvement in treatment
compared to existing therapies. The FDA expedites the approval process for
such a sNDA and targets a decision by six months. Acceptance of the filing
indicates the FDA has determined that the sNDA is sufficiently complete to
permit a substantive review.
"Receiving Priority Review is a significant step forward in accelerating
and expanding the potential of VELCADE in cancers beyond multiple myeloma,"
said Deborah Dunsire, M.D., President and CEO, Millennium. "Our mantle cell
lymphoma application, for which we can expect a decision from the FDA by
December 9, 2006, is the first step in an advanced NHL development program
exploring the use of VELCADE in this large and growing patient population in
need of new treatment options."
The sNDA submission was based on final Phase II data from the PINNACLE
study, one of the largest multi-center studies in relapsed MCL to date, which
showed a 33 percent overall response rate and an 8 percent complete response
rate. Importantly, the median duration of response was 9.2 months, and 13.5
months in patients who achieved a complete response. These results are
similar to those of four investigator initiated Phase II clinical trials where
overall response rates of 30 to 40 percent with single-agent VELCADE were
established.
PINNACLE Study
In the prospective, single-arm study, 155 patients with relapsed or
refractory MCL with a maximum of two prior therapies, received single-agent
VELCADE 1.3mg/m2 twice weekly for two weeks every 21 days for up to one year.
Patients achieving complete response, unconfirmed complete response or partial
response received a median of eight treatment cycles, and all patients in the
study received a median of four cycles. Study results included:
* Overall response rate of 33 percent
* Complete response rate of 8 percent
* Median duration of response of 9.2 months; 13.5 months in patients
achieving a complete response
* Median time to progression of 6.2 months
* Median treatment-free interval of 13.8 months in patients achieving a
complete response
* Treatment was well tolerated. The most common non-hematologic adverse
events were fatigue, gastrointestinal events and peripheral neuropathy.
Hematologic toxicities were mild to moderate and consistent with those
previously seen with VELCADE.
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