FDA News


FDA Grants Breakthrough Therapy Designation for MPDL3280A, an anti-PDL1 Investigational Cancer Immunotherapy for Non-Small Cell Lung Cancer (February 26, 2015)

CancerConnect News: The investigational cancer immunotherapy MPDL3280A (anti-PDL1) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). The designation was granted... Continue Reading

Farydak® Approval Provides Another Treatment Option for Patients With Multiple Myeloma (February 25, 2015)

Novartis announced today that the US Food and Drug Administration (FDA) has approved Farydak® (panobinostat) in combination with Velcade® and dexamethasone for the treatment of patients with multiple... Continue Reading

FDA Approves New Indication for Ibrutinib in Waldenström’s Macroglobulinemia (February 24, 2015)

CancerConnect News: The US Food and Drug Administration (FDA) today expanded the approved use of Imbruvica® (ibrutinib) for patients with Waldenström’s macroglobulinemia, a rare type of B-cell lymphoma.... Continue Reading

U.S. FDA Issues Warning about Certain Type of Endoscope (February 20, 2015)

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication about a certain type of endoscope­—specifically the device used in endoscopic retrograde cholangiopancreatography (ERCP).... Continue Reading

Intravenous Administration of Erwinaze® Approved by FDA (February 18, 2015)

CancerConnect News: The U.S. Food and Drug Administration (FDA) recently approved the intravenous administration of Erwinaze® (asparaginase Erwinia chrysanthemi).  Erwinaze is utilized as a component... Continue Reading

YONDELIS® (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma (February 4, 2015)

The U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for YONDELIS® (trabectedin) to treat patients with advanced soft tissue sarcoma (STS), including... Continue Reading

CPX-351 Receives Fast Track Designation for Secondary Acute Myeloid Leukemia in Elderly Patients (January 28, 2015)

The U. S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigational drug CPX-351, a liposomal formulation of cytarabine-daunorubicin, for the treatment of elderly patients... Continue Reading

FDA Grants Fast Track Designation to SGX301 for First-Line Treatment of Cutaneous T-Cell Lymphoma (January 19, 2015)

The U. S. Food and Drug Administration has granted Fast Track designation the synthetic hypericin (SGX301) development program for the first-line treatment of cutaneous T-cell lymphoma. Fast Track designation... Continue Reading

FDA Approves Gazyva® (Obinutuzumab) Supplemental Biologics License Application with New Data in Previously Untreated Chronic Lymphocytic Leukemia (January 15, 2015)

Genentech announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for Gazyva in combination with chlorambucil chemotherapy in people with... Continue Reading

FDA Approves Blinatumomab for Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (January 12, 2015)

On December 3, 2014, the U. S. Food and Drug Administration granted accelerated approval for BLINCYTOTM (blinatumomab) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell... Continue Reading

FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer (January 8, 2015)

The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC). The most common type of lung cancer,... Continue Reading

FDA Approves Nivolumab for Advanced Melanoma (December 23, 2014)

CancerConnect News: The FDA granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a PD-1 inhibitor, is... Continue Reading

Actinium Receives Orphan-drug Designation from FDA for Actimab-A in the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Elderly Patients (December 8, 2014)

Actinium Pharmaceuticals, Inc., a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the US Food and Drug Administration... Continue Reading

Avastin Approved by the FDA for Recurrent Ovarian Cancer (December 2, 2014)

The FDA approval was based on the results of the AURELIA clinical trial, which involved 361 women with ovarian cancer that had recurred less than 6 months after their most recent platinum-based chemotherapy... Continue Reading

MM-398 Receives Fast Track Designation for Advanced Pancreatic Cancer (November 26, 2014)

The U. S. Food and Drug Administration (FDA) has granted MM- 398 plus 5-fluorouracil (5-FU) and leucovorin a Fast Track designation as a second-line treatment for patients with metastatic pancreatic cancer,... Continue Reading

FDA Approves Cyramza™ in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (November 13, 2014)

The U.S. Food and Drug Administration(FDA) has approved Cyramza™ (ramucirumab) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction... Continue Reading

Novel Agent Granted Fast Track Designation for Refractory Metastatic Colorectal Cancer (October 23, 2014)

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAS-102, a novel agent currently under investigation for the treatment of refractory metastatic colorectal cancer. According... Continue Reading

FDA Grants Breakthrough Therapy Designation to AP26113 for ALK-Positive NSCLC (October 22, 2014)

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to an investigational agent AP26113 for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small... Continue Reading

Next Page »

Sign up for the CancerConnect newsletter

Sign up for our newsletter and receive the latest news and updates about specific types of cancer.

  Close |  Please don't show me this again

Facebook Twitter RSS