Oncology Product Guide » FDA

BioSante Announces FDA Orphan Drug Designation For GVAX Chronic Myeloid Leukemia Cancer Vaccine

Jim Marino — Fri, 11 Jun 2010 11:45:28 +0000

BioSante Pharmaceuticals, Inc. has announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA’s Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease that affects almost 200,000 Americans. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity.

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Sirtex Announces Creation of Centers of Excellence Program

Jim Marino — Thu, 10 Dec 2009 13:21:27 +0000

Sirtex Medical Inc. has announced the development and implementation of the Centers of Excellence (COE) Program. The COE designation recognizes premier hospitals and medical centers in the United States that have made significant contributions to interventional oncology research and clinical practice, including the use of SIR-Spheres microspheres. Manufactured by Sirtex, SIR-Spheres microspheres are the only FDA-approved radioactive microsphere therapy for the treatment of colorectal liver metastases.

Guided Therapeutics Non-Invasive Cervical Cancer Detection Device Trial Confirms Current Tests Miss Disease

Jim Marino — Thu, 26 Nov 2009 15:17:28 +0000

Results of the FDA pivotal clinical trial for the LightTouch Non-invasive Cervical Cancer Detection Device conducted by Guided Therapeutics, Inc. (GT), indicated that the current system for diagnosing cervical disease missed the same amount of disease as a landmark study carried out by the National Cancer Institute (NCI). In the new LightTouch study, 32% of cervical precancers and cancers were missed by the current method of human papillomavirus (HPV) testing and colposcopy.

GlaxoSmithKline receives FDA approval for advanced renal cell carcinoma treatment

Jim Marino — Thu, 22 Oct 2009 14:48:08 +0000

GlaxoSmithKline has received approval from the US Food and Drug Administration (FDA) for the Votrient (pazopanib) drug. The drug is approved for the treatment of patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. The FDA’s Oncologic Drugs Advisory Committee (ODAC) had earlier voted unanimously in favor of the drug due to encouraging results from the phase III trial.

Spectrum Pharma Fusilev fails to get FDA approval as metastatic colorectal cancer treatment

Jim Marino — Thu, 15 Oct 2009 03:24:16 +0000

Spectrum Pharmaceuticals has not received the FDA approval for the supplementary marketing application for its advanced metastatic colorectal cancer drug Fusilev. Fusilev is already approved for use after high-dose methotrexate therapy in osteosarcoma. It is also approved to decrease the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent over dosage of folic acid antagonists.

OncoGenex metastatic prostate cancer drug candidate given “fast track designation”

Jim Marino — Thu, 08 Oct 2009 05:56:18 +0000

OncoGenex Pharmaceuticals Inc said that the US Food & Drug Administration (FDA) has given a “fast track designation” for the company’s metastatic prostate cancer drug candidate. The OGX-O11 drug, also known as custirsen sodium, when combined with first-line docetaxel (chemotherapy) treatment, has been given the designation, which is only given to drugs “that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease.”

Spectrum Pharma receives FDA approval for Zevalin

Jim Marino — Thu, 17 Sep 2009 03:46:12 +0000

Spectrum Pharmaceuticals Inc has received the FDA approval for its Zevalin as a treatment for non-Hodgkin’s lymphoma, a blood cancer. Zevalin was previously used only for patients who had tumors that had not responded to other treatments. The FDA approval was granted on the basis of a phase-three study in which 414 patients showed partial or complete response after receiving a first-line chemotherapy regimen and Zevalin.

FDA accepts Cell Therapeutics NDA for cancer drug

Jim Marino — Thu, 27 Aug 2009 04:51:23 +0000

The US health regulators have accepted and filed for review Cell Therapeutics Inc’s application seeking marketing approval for its experimental drug to treat a type of cancer that affects the lymphatic system. The FDA has designated a standard review for pixantrone as a treatment for relapsed, aggressive non-Hodgkin’s lymphoma, the company said.

Teva receives approval for generic Eloxatin

Jim Marino — Thu, 13 Aug 2009 04:09:13 +0000

Teva Pharmaceutical Industries Ltd began selling a generic injectable version of Eloxatin, a chemotherapy drug, after the approval of the FDA. The oxaliplatin drug is available in 50 mg and 100 mg dosage. The US sales of Eloxatin totaled $1.3 billion in 2008 and the drug is approved to treat advanced colon cancer and stage III colon cancer following surgery.

Genentech receives FDA approval for kidney cancer treatment

Jim Marino — Thu, 06 Aug 2009 11:36:02 +0000

The FDA has approved Genentech’s cancer treatment Avastin (bevacizumab) for kidney cancer. Avastin blocks new blood vessels from forming and supplying tumors with the nutrients they need to grow and spread to other parts of the body. This drug is already being used for the treatment of colorectal cancer, breast cancer and non-small cell lung cancer and is being tested for the treatment of more than 30 tumor types.