Takeda receives FDA approval for VELCADE sNDA to treat MM

Nov 2 2011

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term (median follow-up 60.1 months) overall survival (OS) data from the VISTA trial. The landmark VISTA trial examined the use of VELCADE-based therapy in patients with previously untreated multiple myeloma (MM).

The 5-year follow-up data demonstrated that patients treated with VELCADE, melphalan and prednisone (VcMP) continued to have a statistically significantly longer OS (median OS 56.4 versus 43.1 months, p<0.05) than those treated with melphalan and prednisone (MP) alone, a recognized standard of care. These results translated into a 43.9 percent improvement in OS when patients received the VELCADE containing regimen. A complete data set from the trial will be presented at the upcoming meeting of the American Society of Hematology.

An earlier analysis (median follow-up of 36.7 months), demonstrated that starting with the VELCADE combination (VcMP) provided a statistically significant OS advantage over MP that was not regained despite the use of subsequent therapies including VELCADE-based regimens.

The VISTA trial is the largest Phase III registration study to report long-term OS in previously untreated multiple myeloma patients. This multicenter, international 682-patient clinical trial compared VcMP to MP in patients with previously untreated MM who were not eligible for stem cell transplantation. The safety profile of VELCADE in combination with MP was consistent with the known safety profiles of both VELCADE and MP. This study was conducted by Millennium and its co-development partner Johnson & Johnson Pharmaceutical Research & Development (J&JPRD).

The prescribing information is also being updated to provide the information that the concomitant use of strong CYP3A4 inducers with VELCADE is not recommended.

In VISTA, the most commonly reported adverse events for VELCADE in combination with MP vs MP, respectively, were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%).