2010 Notifications

To view 2010 Notification information, please see the FDA Archive.

FDA granted approval for denosumab (Xgeva, Amgen Inc.) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Denosumab is not indicated for the prevention of SREs in patients with multiple myeloma. More Information⁶⁴ (November 18, 2010)
FDA granted approval for eribulin mesylate (Halaven Injection, Eisai Inc.) for the treatment of patients with metastatic breast cancer who have previously received an anthracycline and a taxane in either the adjuvant or metastatic setting, and at least two chemotherapeutic regimens for the treatment of metastatic disease. More Information⁶⁵ (November 15, 2010)
This notice is to inform you of important new safety information regarding the already labeled adverse reaction of oligohydramnios (decreased amniotic fluid). Based on post-marketing adverse event reports, cases of oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported in the offspring of mothers exposed to trastuzumab (Herceptin, Genentech Incorporated) during pregnancy. More Information⁶⁶ (November 1, 2010)
FDA granted accelerated approval to everolimus (Afinitor, Novartis), an mTOR inhibitor, for patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require therapy but are not candidates for surgical resection. Afinitor was originally approved in March 2009 for the treatment of adult patients with advanced renal cell carcinoma (RCC) whose disease was resistant to sunitinib or sorafenib. More Information⁶⁷ (October 29, 2010)
FDA granted accelerated approval to dasatinib (Sprycel, Bristol-Myers Squibb), an orally administered kinase inhibitor, for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (CP-CML). The recommended dasatinib dose for this indication is 100 mg orally once daily. Sprycel was originally approved in June 2006 for the treatment of adult patients with CP-CML resistant or intolerant to prior therapy that included imatinib. More Information⁶⁸ (October 28, 2010)
FDA granted approval for trastuzumab (Herceptin), Genentech, Inc.), in combination with cisplatin and a fluoropyrimidine (capecitabine or 5â€‘fluorouracil), for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal (GE) junction adenocarcinoma, who have not received prior treatment for metastatic disease. More Information⁶⁹. (October 20, 2010)
This communication is to inform members of the oncology community of recent changes in the measurement of serum creatinine which may have an impact on carboplatin dosing. Based on preliminary communications with the National Cancer Institute/Cancer Therapy Evaluation Program, a potential safety issue with carboplatin dosing has been identified. More Information⁷⁰ (October 10, 2010).
Pfizer Inc., in agreement with the FDA, announced that the commercial marketing of Mylotarg (gemtuzumab ozogamicin) will be voluntarily discontinued, and the new drug application (NDA) for Mylotarg will be withdrawn as of October 15, 2010. More Information⁷¹ (June 21, 2010)
FDA granted accelerated approval to nilotinib (Tasigna Capsules, Novartis Pharmaceuticals Corporation), an orally administered kinase inhibitor, for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP-CML). More information⁷² (June 17, 2010)
FDA approved cabazitaxel (Jevtana Injection, sanofi-aventis) for use in combination with prednisone for treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. More Information⁷³ (June 17, 2010)
FDA approved hexaminolevulinate hydrochloride (Cysview for Intravesical Solution, Photocure ASA), as an optical imaging agent for use in combination with the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. More Information⁷⁴ (May 28, 2010)
FDA approved erlotinib (Tarceva) tablets for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. More Information⁷⁵ (April 16, 2010)
FDA has been informed by Lundbeck, Inc., the sole worldwide manufacturer of Mustargen (mechlorethamine HCl for injection), that there will be an extended supply shortage of this drug. More Information⁷⁶ (April 9, 2010)
FDA granted approval to rituximab (Rituxan, Genentech), in combination with fludarabine and cyclophosphamide (FC), for the treatment of previously untreated and previously treated patients with chronic lymphocytic leukemia (CLL). More Information⁷⁷ (February 18, 2010)
FDA approved a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs). The medications included in the program are marketed by Amgen under the names Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and by Centocor Ortho Biotech Products under the name Procrit (epoetin alfa). FDA required Amgen, the manufacturer of these products, to develop the REMS based on studies demonstrating that use of ESAs can increase the risk of tumor growth and shorten survival in patients with cancer. More Information⁷⁸ (February 16, 2010)
FDA granted accelerated approval to Tykerb (lapatinib) tablets for use in combination with letrozole tablets for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. More Information⁷⁹ (January 29, 2010)