Millennium Files sNDA for VELCADE(R) (Bortezomib) for Injection in Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Friday June 9, 8:01 am ET
CAMBRIDGE, Mass., June 9 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced the Company has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for VELCADE in the treatment of relapsed or refractory mantle cell lymphoma (MCL), an aggressive subtype of non-Hodgkin's lymphoma (NHL) that is not curable. The filing is based on final data from the Phase II PINNACLE trial, one of the largest multi-center studies in relapsed MCL to date, which showed a 33 percent overall response rate and an eight percent complete response rate. Importantly, the median duration of response was 9.2 months; 13.5 months in patients achieving a complete response. These results are similar to four other Phase II clinical trials that recorded overall response rates of 30 to 40 percent with single-agent VELCADE.
"This is a significant milestone for the Company and highlights the potential of VELCADE to treat a very aggressive cancer that does not currently have a standard of care," said Deborah Dunsire, M.D., President and CEO, Millennium. "The results from multiple Phase II mantle cell studies are part of our larger NHL program that includes an ongoing Phase III follicular lymphoma trial. The sNDA filing also represents another step forward to expand the role of VELCADE in order to meet the needs of patients with a variety of cancers."
Currently, VELCADE has been approved by the FDA for the treatment of multiple myeloma patients who have received at least one prior therapy. To date, over 33,000 multiple myeloma patients have been treated with VELCADE worldwide. Earlier this year, Millennium and co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), initiated a Phase III clinical trial with VELCADE in combination with rituximab in patients with relapsed or refractory follicular lymphoma.
PINNACLE Study
In the prospective, single-arm study, presented at the American Society of Clinical Oncology (ASCO) 42nd Annual Meeting, 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 (CR), unconfirmed complete response (CRu) or partial response (PR) 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 (CR + CRu + PR)
* Complete response rate of 8 percent (CR + CRu)
* Median duration of response (DOR) of 9.2 months; 13.5 months in patients
achieving a complete response
* Median time to progression (TTP) 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 consistent with those previously seen with VELCADE.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the U.S.(1) The prevalence of NHL is approximately 400,000 patients, 77,000 patients with follicular lymphoma and 10,000 with mantle cell lymphoma. There are approximately 54,000 new cases of NHL diagnosed per year, and 19,000 deaths are attributed to the disease annually(2,3).
Mantle cell lymphoma is an aggressive, rapidly progressive subtype of non- Hodgkin's lymphoma, and is not curable with standard treatment. Because there is no generally accepted treatment approach and options often are limited, there is a growing need for new therapies. The average life expectancy for a patient with relapsed mantle cell lymphoma is 1-2 years. |
