Hematology/Oncology (Cancer) Approvals & Safety Notifications

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2012

• FDA approved bosutinib tablets (Bosulif, Pfizer, Inc.) for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior therapy. More Information.  September 4, 2012
• FDA approved enzalutamide (XTANDI Capsules, Medivation, Inc. and Astellas Pharma US, Inc.), for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. More Information.  August 31, 2012
• FDA granted accelerated approval for everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the treatment of pediatric and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. More Information. August 30, 2012
• FDA granted accelerated approval for vinCRIStine sulfate LIPOSOME injection (Marqibo, Talon Therapeutics, Inc.) for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.  More Information.  August 9, 2012
• FDA approved ziv-aflibercept injection (ZALTRAP, Sanofi U.S., Inc.) for use in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin containing regimen. More Information.  August 3, 2012
• FDA approved everolimus tablets (Afinitor®, Novartis Pharmaceuticals Corporation) for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. More Information.  July 20, 2012
• FDA granted accelerated approval to carfilzomib injection (Kyprolis, Onyx Pharmaceuticals), for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of the completion of the last therapy.  More Information.  July 20, 2012
• FDA granted approval to cetuximab (Erbitux, ImClone LLC, a wholly owned subsidiary of Eli Lilly and Co) for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment of patients with K-ras mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use.
  FDA also approved the Therascreen KRAS RGQ PCR Kit (QIAGEN Manchester, Ltd) concurrent with this cetuximab approval. More Information.  July 9, 2012
• FDA approved pertuzumab injection (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of HER2, and thereby blocks ligand-dependent heterodimerization of HER2 with other HER family members, including EGFR, HER3 and HER4. More Information.  June 8, 2012
• FDA approved pazopanib tablets (VOTRIENT, a registered Trademark of GlaxoSmithKline) for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.  The efficacy of pazopanib for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated. More Information.  April 26, 2012 
• FDA granted accelerated approval to everolimus (Afinitor tablets, Novartis) for the treatment of adults with renal angiomyolipoma, associated with tuberous sclerosis complex (TSC), who do not require immediate surgery. More Information.  April 26, 2012
• FDA announced major actions taken to bolster the supply of Doxil (Janssen Research and Development LLC) and preservative-free formulations of methotrexate.  In response to the critical shortage of Doxil (doxorubicin hydrochloride liposome injection) effective immediately FDA is exercising its enforcement discretion for the temporary importation and distribution of Sun Pharma Global's Lipodox.  More Information February 21, 2012
• FDA granted regular approval for imatinib mesylate tablets (Gleevec, Novartis Pharmaceuticals) for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumors (GIST). Accelerated approval for this indication was granted in December 2008. Labeling is also revised to include the results of a randomized trial demonstrating that recurrence-free survival (RFS) and overall survival (OS) were improved by continuing adjuvant imatinib therapy to 36 months. More Information (January 31, 2012)
• FDA approved vismodegib (ERIVEDGE Capsule, Genentech, Inc.) for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.  More Information (January 30, 2012)
• FDA approved axitinib tablets (Inlyta, Pfizer, Inc.) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. More Information (January 27, 2012)
• FDA approved glucarpidase  injection (Voraxaze, BTG International Inc.) for the treatment of toxic plasma methotrexate concentrations (> 1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function. More Information (January 17, 2012)

2011

• FDA has approved changes to the package inserts for methotrexate products for intravenous administration.  Additional information has been added to the WARNING section of the Label.  More Information (December 21, 2011)
• FDA approved changes to the Risk Evaluation and Mitigation Strategies (REMS) for romiplostim (Nplate for subcutaneous injection, Amgen Inc.) and eltrombopag (Promacta tablets, GlaxoSmithKline LLC) to remove the restricted distribution programs and the safety reporting requirements that were part of the REMS. Prescriber, institution, pharmacy, and patient enrollment and these data collection requirements are no longer necessary. More Information (December 6, 2011)
• FDA approved asparaginase Erwinia chrysanthemi [Erwinaze, injection, EUSA Pharma (USA), Inc.] as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. More Information (November 18, 2011)
• FDA approved ruxolitinib (Jakafi oral tablets, Incyte Corporation) for the treatment of intermediate and high risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. Results of two randomized controlled trials in patients with intermediate or high risk myelofibrosis comparing ruxolitinib to placebo (Study 1) or to best available therapy (Study 2) were the basis of approval.  More Information (November 16, 2011)
• FDA approved cetuximab (Erbitux, ImClone LLC, a wholly-owned subsidiary of Eli-Lilly and Company) in combination with platinum-based therapy plus 5-florouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). More Information (November 7, 2011)
• FDA granted accelerated approval to deferiprone (Ferriprox Tablets, ApoPharma, Inc.), an oral iron chelator for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. More Information (October 14, 2011)
• Changes in bevacizumab (Avastin, Genentech, Inc.) package insert regarding: risk of ovarian failure, osteonecrosis of the jaw, risk of venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after first VTE event. More Information (September 30, 2011)
• FDA granted accelerated approval for the use of eculizumab (Soliris, Alexion, Inc.) for the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS).  More Information (September 23, 2011)
• FDA granted approval for denosumab (Prolia, Amgen Inc.) as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer or adjuvant aromatase inhibitor (AI) therapy for breast cancer. In men with nonmetastatic prostate cancer, denosumab also reduced the incidence of vertebral fracture. More Information (September 16, 2011)
• FDA granted accelerated approval to granted accelerated approval to crizotinib (XALKORI Capsules, Pfizer Inc.) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.  The FDA approved the Vysis ALK Break-Apart FISH Probe Kit (Abbott Molecular, Inc.) concurrently with the crizotinib approval.  This companion diagnostic test is designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in NSCLC. More Information (August 26, 2011)
• FDA granted accelerated approval to brentuximab vedotin (Adcetris for Injection, Seattle Genetics, Inc.) for two indications: (1) treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen.  More Information (August 19, 2011)
• FDA approved vemurafenib tablets (ZELBORAF, Hoffmann-La Roche Inc.) for the treatment of patients with unresectable or metastatic melanoma with the BRAF^V600E mutation as detected by an FDA-approved test.  More Information (August 17, 2011) 
• FDA approved sunitinib (Sutent Capsules, Pfizer, Inc.) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable, locally advanced, or metastatic disease. More Information (May 20, 2011)
• FDA approved everolimus (Afinitor Tablets, Novartis Pharmaceuticals Corporation), for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease.  The safety and effectiveness of everolimus in the treatment of patients with carcinoid tumors have not been established. More Information (May 5, 2011)
• FDA approved abiraterone acetate (Zytiga Tablets, Centocor Ortho Biotech, Inc.) for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel.  More Information (April 28, 2011) 
• FDA approved vandetanib tablets (Vandetanib Tablets, AstraZeneca Pharmaceuticals LP), a kinase inhibitor, for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable, locally advanced, or metastatic disease. The use of vandetanib in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment-related risks of vandetanib.  More Information (April 6, 2011)
• FDA approved peginterferon alfa-2b (Sylatron, Schering Corporation, Kenilworth, NJ 07033), for the treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. More Information (March 29, 2011)
• FDA approved ipilimumab injection (YERVOY, Bristol-Myers Squibb Company) for the treatment of unresectable or metastatic melanoma.  More Information. (March 25, 2011)
• FDA approved rituximab (Rituxan, Genentech, Inc) for maintenance therapy for patients with previously untreated follicular, CD-20 positive, B-cell non-Hodgkin lymphoma who achieve a response to rituximab in combination with chemotherapy. More Information (January 28, 2011)

2010

• 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 Information (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 Information (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 Information (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 Information (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 Information (October 28, 2010)
• FDA granted approval for trastuzumab (Herceptin), Genentech, Inc.), in combination with cisplatin and a fluoropyrimidine (capecitabine or 5‑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 Information. (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 Information (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 Information (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 information (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 Information (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 Information (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 Information (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 Information (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 Information (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 Information (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 Information (January 29, 2010)

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