Bortezomib Median Overall Survival Update for Previously Untreated Multiple Myeloma

The US Food and Drug Administration (FDA) has approved a supplemental new drug application for Velcade (bor tezomib) for Injection (Millennium: The Takeda Oncology Company) that updates the label to include additional longterm (median follow-up 60.1 months) overall survival (OS) data from the VISTA trial. The VISTA trial examined the use of bortezomib-based therapy in patients with previously untreated multiple myeloma (MM).

The 5-year follow-up data demonstrated that patients treated with bortezomib, melphalan, and prednisone (VcMP) continued to have a statistically significantly longer OS (median OS 56.4 vs 43.1 months, P <.05) than those treated with melphalan and prednisone (MP) alone, a recognized standard of care. These results translated into a 43.9% improvement in OS when patients received the bortezomibcontaining regimen. A complete data set from the trial was presented at the December 2011 meeting of the American Society of Hematology.

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

The VISTA trial is the largest phase 3 registration study to report long-term OS in previously untreated MM 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 bortezomib in combination with MP was consistent with the known safety profiles of both bortezomib and MP.

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

In VISTA, the most commonly reported adverse events for bortezomib in combination with MP versus MP, respectively, included 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%), and edema peripheral (20% vs 10%). Other noted adverse events for both combinations were rash, back pain, pneumonia, dizziness, dyspnea, headache, pain in extremity, abdominal pain, paresthesia, herpes zoster, bronchitis, hypokalemia, hypertension, upper abdominal pain, hypotension, dyspepsia, naso pharyngitis, bone pain, arthralgia, and pruritus.