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Hematology/Oncology (Cancer) Approvals & Safety Notifications

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2014

  • FDA approved siltuximab (Sylvant  Injection Janssen Biotech, Inc.), for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV-) -negative and human herpes virus -8 (HHV-8) -negative.  More Information.  April 23, 2014. 
  • FDA approved ramucirumab (Cyramza, Eli Lilly and Company) for use as a single agent for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy.  Ramucirumab is a recombinant monoclonal antibody of the IgG1 class that binds to vascular endothelial growth factor receptor-2 (VEGFR-2) and blocks the activation of the receptor. More Information.  April 21, 2014
  • FDA approved ofatumumab (Arzerra Injection, for intravenous infusion; GlaxoSmithKline) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. More Information.  April 17, 2014
  • FDA granted accelerated approval to ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.  Ibrutinib previously received accelerated approval on November 13, 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. More Information.  February 12, 2014
  • FDA granted accelerated approval to trametinib (Mekinist tablets, GlaxoSmithKline, LLC) and dabrafenib (Tafinlar capsules, GlaxoSmithKline, LLC) for use in combination in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test. More Information.  January 10, 2014

2013 

  • FDA approved sorafenib (NEXAVAR tablets, Bayer Healthcare Pharmaceuticals Inc.) for the treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment.  Sorafenib was previously approved for treatment of renal cell carcinoma (2005) and hepatocellular carcinoma (2007) More Information.  November 22, 2013

  • FDA granted regular approval for crizotinib (Xalkori, Pfizer, Inc.) capsules for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. More Information.  November 20, 2013

  • FDA granted accelerated approval to Ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.  More Information.  November 13, 2013

  • FDA approved obinutuzumab (GAZYVA injection, for intravenous use, Genentech, Inc.; previously known as GA101) for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). More Information.  November 1, 2013

  • FDA has asked the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) to suspend marketing and sales of Iclusig because of the risk of life-threatening blood clots and severe narrowing of blood vessels.  More Information.  October 31, 2013

  • FDA provided information on the availability of doxorubicin hydrochloride liposome injection to supply the U.S. market. More Information. October 8, 2013 

  • FDA granted accelerated approval to pertuzumab injection (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. More Information. September 30, 2013

  • FDA approved paclitaxel protein-bound particles (albumin-bound) (Abraxane for injectable suspension, Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation), in combination with gemcitabine for the first-line treatment of patients with metastatic adenocarcinoma of the pancreasMore Information.  September 6, 2013

  • FDA approved afatinib (Gilotrif tablets, Boehringer Ingelheim Pharmaceuticals, Inc.), for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.  The safety and efficacy of afatinib have not been established in patients whose tumors have other EGFR mutations.  Concurrent with this action, FDA approved the therascreen EGFR RGQ PCR Kit (QIAGEN) for detection of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. More Information.  July 12, 2013
  • FDA approved denosumab (Xgeva injection, for subcutaneous use, Amgen Inc.) for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. More Information. June 13, 2013
  • FDA approved lenalidomide capsules (REVLIMID, Celgene Corporation), for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. More Information.  June 5, 2013
  • FDA approved trametinib (MEKINIST tablet, GlaxoSmithKline, LLC), for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an FDA-approved test. More Information. May 29, 2013
  • FDA approved dabrafenib (TAFINLAR capsule, GlaxoSmithKline, LLC), for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. More Information. May 29, 2013
  • FDA approved radium Ra 223 dichloride (Xofigo Injection, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.  Xofigo is an alpha-particle emitting radiotherapeutic drug which mimics calcium and forms complexes with hydroxyapatite at areas of increased bone turnover, such as bone metastases. More Information.  May 15, 2013
  • FDA approved erlotinib (Tarceva, Astellas Pharma Inc.) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.  This indication for erlotinib is being approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic test for patient selection. More Information.  May 14, 2013
  • FDA approved ado-trastuzumab emtansine (KADCYLA for injection, Genentech, Inc.), for use as a single agent for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.   Patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy. More Information.  February 22,2013
  • FDA granted accelerated approval to pomalidomide (POMALYST capsules, Celgene Corporation) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy. More Information.  February 8, 2013
  • FDA approved doxorubicin hydrochloride liposome injection (Sun Pharma Global FZE), a generic version of DOXIL Injection (doxorubicin hydrochloride liposome; Janssen Products, L.P.) for the treatment of ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy and for AIDS-related Kaposi’s sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy. More Information.  February 4, 2013
  • FDA approved bevacizumab (Avastin, Genentech U.S., Inc.) for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first-line bevacizumab-containing regimen. More Information.  January 23, 2013

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