Genentech, Inc. and Biogen Idec, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved, after a Priority Review, two additional uses for Rituxan® (rituximab) for patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). One new indication for Rituxan is for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. The second new indication is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy. In February 2006, Rituxan in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy was approved as first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). Rituxan was approved in 1997 as a single agent for patients with relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL.
Amgen Inc. announced that the FDA has approved its fully human monoclonal antibody Vectibix™ (panitumumab) for the treatment of patients with metastatic colorectal cancer. The FDA approved Vectibix for patients with colorectal cancer that has spread during or after chemotherapy and who are expressing epidermal growth factor receptors. Vectibix binds to EGF receptors and interferes with the signal that might otherwise stimulate growth of cancer cells. Amgen expects Vectibix to go on sale in early-to-mid October and to cost approximately 20 percent less than the other anti-EGFr antibody now on the market.
Cephalon Inc. announced that the FDA has approved its drug Fentora® for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Cephalon expects Fentora to be available in the United States during the first week of October. Fentora is a sugar-free tablet that contains fentanyl, the same active ingredient found in Actiq. Fentora is the first and only buccal tablet indicated for the management of breakthrough pain in opioid-tolerant patients with cancer, and the first tablet formulation of fentanyl approved for any use. Its proprietary OraVescent® drug delivery system was developed by Cephalon subsidiary CIMA.
Callisto Pharmaceuticals has been granted orphan drug designation for Atiprimod, its drug candidate for carcinoid tumors. Atiprimod is a small molecule orally available drug with antiproliferative and antiangiogenic activity. Callisto plans to begin a single-agent Phase II trial of Atiprimod in advanced carcinoid cancer patients in the third quarter of 2006. The drug has been shown to inhibit secretion of VEGF and IL-6, elicit an apoptotic response, and inhibit phosphorylation of key kinases involved in tumor progression and survival, including Akt and STAT3.
The FDA has granted orphan drug designation to Threshold Pharmaceutical's product candidate, Glufosfamide, for the treatment of pancreatic cancer. Last month the company announced that it had completed enrollment in a pivotal phase 3 clinical trial evaluating glufosfamide for the potential second-line treatment of pancreatic cancer and a phase 2 clinical trial evaluating glufosfamide in combination with gemcitabine for the potential first-line treatment of pancreatic cancer.
On July 14, 2006, FDA approved Gemzar (gemcitabine) in combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy.
GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) approved Hycamtin (topotecan hydrochloride) in combination with cisplatin, for the treatment of stage IV-B, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy. The FDA approved the new use under a six-month priority review. GlaxoSmithKline stated that the expanded indication is based on Phase III results that demonstrated a survival advantage by using Hycamtin in combination with cisplatin compared to cisplatin alone.
Celgene Corporation announced that the FDA has granted approval for its Supplemental New Drug Application (sNDA) for an additional indication for Revlimid (lenalidomide), for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy
The FDA has approved Sprycel (dasatinib) for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance to prior therapy. Bristol-Myers Squibb anticipates that Sprycel will be available within a few days nationwide. Note: The FDA has granted accelerated approval of Sprycel for the treatment of adults in all phases of chronic myeloid leukemia with resistance or intolerance to prior therapy, including Gleevec (imatinib mesylate)
Genentech, Inc. announced that the FDA approved Avastin (bevacizumab) in combination with intravenous 5-fluorouracil (5-FU)-based chemotherapy for second-line metastatic colorectal cancer. The approval is based on results of a randomized, controlled, multicenter Phase III trial (E3200) of 829 patients with advanced or metastatic CRC who had received previous treatment with irinotecan and 5-FU as initial therapy for metastatic disease or as adjuvant therapy. The study showed that patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 25 percent reduction in the risk of death (based on a hazard ratio of 0.75), the primary endpoint, which is equivalent to a 33 percent improvement in overall survival, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 13.0 months, compared to 10.8 months for those receiving FOLFOX4 alone.
May 10, 2006
U.S. FDA Approves Dacogen™ (DECITABINE) FOR INJECTION (—Dacogen™ Approved for Patients with all FAB Classifications of MDS——Commercial Launch Planned For Late May—)
MGI PHARMA, INC. (Nasdaq: MOGN) and SuperGen, Inc. (Nasdaq: SUPG) have announced that the U.S. Food and Drug Administration (FDA) has approved Dacogen™ (decitabine) for Injection. Dacogen is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo, and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System (IPSS) groups. MGI PHARMA plans to make Dacogen commercially available during the second quarter of 2006.
April 2006
Taxotere® (docetaxel) - Following a priority review of the supplemental new drug application (sNDA), the FDA has approved Taxotere® (docetaxel) Injection Concentrate in combination with cisplatin and 5-fluorouracil for the treatment of patients with advanced stomach cancer, including cancer of the gastro esophageal junction, who have not received prior chemotherapy for advanced disease. The FDA based its decision on results from the TAX 325 study, the largest international Phase III clinical trial in previously untreated advanced stomach cancer, involving 445 patients. Patients treated with the Taxotere-based chemotherapy regimen (Taxotere plus cisplatin and 5-fluorouracil, TCF) experienced a significant 23 percent reduction in the risk of death compared to patients who received a current standard treatment of cisplatin and 5-flurouracil, (median follow-up: 23 months). The median overall survival was significantly longer with the Taxotere-containing regimen (9.2 vs 8.6 months, p=<0.02).
Aranesp® (darbepoetin alfa) - The FDA has approved every-three-week dosing of Aranesp® (darbepoetin alfa) for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by the FDA for every-three-week administration
Carboplatin - The abbreviated New Drug Application (ANDA) for Carboplatin Injection (liquid form) in a 600 mg. multi-dose vial has been approved by the FDA, American Pharmaceutical Partners Inc., (Schaumburg, Ill.) announced. The FDA also approved the company’s ANDAs for Octreotide Acetate Injection, single-dose and multiple dose vials.
March 2006
Erbitux® (cetuximab) -The Food and Drug Administration (FDA) has approved Erbitux® (cetuximab) for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed. These indications are based on a Phase III study that demonstrated a survival and locoregional control advantage when Erbitux was added to radiation therapy, and a Phase II study, where Erbitux therapy alone reduced tumor size. Erbitux is an IgG1 monoclonal antibody designed to inhibit the function of epidermal growth factor receptor (EGFR), a molecule structure linked to tumor growth
February 2006
Sutent –The FDA has approved Suent, an anti-cancer treatment for patients with gastrointestinal stromal tumors (GIST) or with advanced kidney cancer.
January 2006
FDA Approves Nexavar for Advanced Renal Cell Carcinoma - The U.S. Food and Drug Administration (FDA) announced Dec. 20 that Nexavar (sorafenib tosylate), distributed and marketed by Bayer Pharmaceuticals Corporation, was approved for treatment of advanced renal cell carcinoma (ARCC), the most common type of kidney cancer
Nexavar, co-developed by Onyx Pharmaceuticals and Bayer and formerly known as Bay 43-9006, is the first oral multikinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature. In preclinical models, sorafenib targeted members of two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) - two important cancer growth activities.
FDA Approves Celgene’s Revlimid for MDS -
Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) granted approval of Revlimid (lenalidomide), which is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid will be available through a Revlimid Education and Prescribing Safety Program, called RevAssist via contracted pharmacies. Most initial shipments of Revlimid to be distributed in early 2006.
OTHER ISSUES & UPDATES:
CLINICAL PRACTICE UPDATE: November 21, 2006 FCSO Antineoplastic Drugs Workgroup Telephone Conference Call Notes
New Articles Posted to Medlearn Matters (posted December 29th, 2005)
SE0588 - Documentation and Coding Guidelines for Medicare’s 2006 Oncology
Demonstration