Degarelix (Firmagon) for prostate cancer: now approved by FDA
Related to EMEA’s positive opinion on degarelix (Firmagon) for prostate cancer, FDA issues this press release dated Dec. 29, 2008: FDA Approves Drug for Patients with Advanced Prostate Cancer The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer.
Ibandronic acid (Bondronat) for the treatment of hypercalcaemia and bony metastases. Australian Prescriber review
From Australian Prescriber: Ibandronic acid Bondronat (Hospira) vials containing 6 mg/6 mL Approved indications: hypercalcaemia, bony metastases of breast cancer Australian Medicines Handbook section 10.3.1 Bisphosphonates can reduce the hypercalcaemia of malignant disease by inhibiting the resorption of bone. Clodronate, pamidronate and zoledronic acid are already available for this indication. They are now
Temsirolimus (Torisel): kinase inhibitor for the treatment of advanced renal cell carcinoma. Australian Prescriber review
From Australian Prescriber: Temsirolimus Torisel (Wyeth) vials containing 25 mg/mL concentrate Approved indication: advanced renal cell carcinoma Australian Medicines Handbook section 14.2.3 About 30% of patients with renal cell carcinoma have advanced or metastatic disease at the time of diagnosis. Chemotherapy is generally ineffective and nephrectomy is the mainstay of treatment for disease confined to […]
Panitumumab (Vectibix) for metastatic colorectal carcinoma. Australian Prescriber review
From Australian Prescriber: Panitumumab Vectibix (Amgen) vials containing 20 mg/mL in 5 mL, 10 mL or 20 mL volume Approved indication: metastatic colorectal carcinoma Australian Medicines Handbook section 14.2.1 Panitumumab is a humanised monoclonal antibody for the treatment of metastatic colorectal carcinomas expressing the epidermal growth factor receptor. It is indicated for patients whose tumours […]
Anti-thymocyte globulin (Thymoglobuline) for renal transplant rejection and aplastic anaemia. Australian Prescriber review
From Australian Prescriber: Anti-thymocyte globulin Thymoglobuline (Genzyme) vials containing 25 mg freeze-dried powder Approved indication: renal transplant rejection and aplastic anaemia Australian Medicines Handbook section 14.5.3 Anti-thymocyte globulin is indicated for the prophylaxis of renal graft rejection as well as the treatment of steroid-resistant renal transplant rejection. Kidney transplantation is the treatment of choice for […]
Genetic variants of cytochrome P-450 linked to decreased response to clopidogrel (Plavix,Iscover and others)
From Physician’s First Watch: Genetic Variants Linked to Decreased Response to Clopidogrel, Increased Cardiovascular Risk Polymorphisms in the gene encoding the cytochrome P-450 2C19 enzyme (CYP2C19) not only confer reduced response to clopidogrel, but also are associated with increased risk for cardiovascular events, according to three studies published online by the New England Journal of […]
Romiplostim (Nplate) for idiopathic thrombocytopenic purpura. Review by Australian Prescriber
Australian Prescriber review of romiplostim, first bone marrow stimulator, for the treatment of idiopathic thrombocytopenic purpura: Romiplostim Nplate (Amgen) vials containing 375 microgram and 625 microgram for reconstitution Approved indication: idiopathic thrombocytopenic purpura Australian Medicines Handbook Appendix A One of the causes of thrombocytopenia is idiopathic thrombocytopenic purpura. As the platelets are destroyed by antiplatelet […]
EMEA: marketing authorisation of Nespo (darbepoetin alfa) withdrawed
EMEA public statement dated 16 December 2008: PUBLIC STATEMENT ONNespo (darbepoetin alfa) WITHDRAWAL OF THE MARKETING AUTHORISATION IN THE EUROPEAN UNION On 8 June 2001 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Nespo, darbepoetin alfa, which had been approved for the treatment of symptomatic anaemia associated […]
EMEA: marketing authorisation of Neupopeg (pegfilgrastim) withdrawed
Public statement dated 16 December 2008: PUBLIC STATEMENT ON Neupopeg (pegfilgrastim) WITHDRAWAL OF THE MARKETING AUTHORISATION IN THE EUROPEAN UNION On 22 August 2002 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Neupopeg, pegfilgrastim, which had been approved for the reduction in the duration of neutropenia and the incidence […]
EMEA press release: CHMP adopted positive opinion about mifamurtide (Mepact) for the treatment of osteosarcoma
EMEA press release informing the CHMP positive opinion about mifamurtide (Mepact), for the treatment of high grade resectable non metastatic osteosarcoma. COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for MEPACT International Nonproprietary Name (INN): mifamurtide On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive […]
FDA approves imatinib (Gleevec) for a new indication: GIST tumors.
FDA press relase about the approval of imatinib (Gleevec) for the treatment of GIST tumors: FOR IMMEDIATE RELEASE December 19, 2008 FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer The U.S. Food and Drug Administration today approved Gleevec (imatinib mesylate) for a new indication –
EMEA press release: CHMP positive opinion about degarelix (Firmagon) for prostate cancer
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for FIRMAGON International Nonproprietary Name (INN): degarelix (as acetate) On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Firmagon, 80 mg and 120 mg, powder and […]
FDA approves plerixafor (Mozobil) for use in multiple myeloma and non Hodgkin’s lymphomas
From the FDA’s newsroom: FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used […]
EMEA’s opinion to designate new orphan drugs
ORPHAN MEDICINAL PRODUCT DESIGNATION The COMP adopted six positive opinions recommending the following medicines for designation as orphan medicinal products to the European Commission: For the following medicines the EMEA review began on 12 September 2008 with an active review time of 90 days.