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City Cambridge / / Company AEs / Millennium Pharmaceuticals Inc. / ccP / ITT / Cox / Johnson & Johnson Pharmaceutical Research & Development L.L.C. / opment L.L.C. / / Country United States / / / Event FDA Phase / Person Communication and Meetings / / Facility Temple R / This laboratory / / IndustryTerm Cancer Treat / bortezomib / validated computer program algorithm / / MedicalCondition dysesthesia / multiple myeloma / headache / plasmacytoma / nausea / thrombocytopenia / peripheral neuropathy / bacterial meningitis / hematologic diseases / Plasmacytomas / diarrhea / cardiac arrest / constipation / infections / asthenia / peripheral neuropathy / sepsis / bortezomib-associated peripheral neuropathy / insomnia / congestive heart failure / measurable disease / disease / plasmacytoma measurements / hyperglycemia / progressive disease / neutropenia / mL/min V20 mL/min Hypercalcemia / amyloidosis / vomiting / cardiogenic shock / hypercalcemia / respiratory insufficiency / cough / paresthesia / Progressive Multiple Myeloma / anemia / Baseline disease / disorders / / MedicalTreatment antibiotics / chemotherapy / blood transfusions / CCR / / MusicGroup Nausea / / Organization Division of Drug Oncology Products / United States Food and Drug Administration / U.S. Food and Drug Administration / FDA / Center for Drug Evaluation and Research / American Association for Cancer Research / / Person Johnson JR / Silver Spring / Robert C. Kane / Rajeshwari Sridhara / Ann Intern Med / Ann T. Farrell / / / Position advisors / Governor / representative / / Product Velcade / dexamethasone / cyclophosphamide / V50 / V20 / CCR-06-0170 / / ProvinceOrState Massachusetts / / PublishedMedium Cancer Research / The FDA review / / TVStation Kyle / / Technology validated computer program algorithm / Transplantation / chemotherapy / http / / URL www.fda.gov/cder/guidance/append4.pdf / www.fda.gov/cder/approval/index/htm / http / SocialTag 
Report from the FDA United States Food and Drug Administration Approval Summary: Bortezomib for theTreatment of Progressive Multiple Myeloma after One Prior Therapy Robert C. Kane, Ann T. Farrell, Rajeshwari Sridhara, a