The US Food and Drug Administration (FDA) on Friday approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML) and for patients aged two years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment.  In 2010, Pfizer voluntarily withdrew the treatment, 10 years after it won accelerated approval, wh...

The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment. "The purpose of this MOU is to engage in scientific and programmatic collaborations in clinical proteogenomics cancer research, such as statistical experimental design, instrument/technolo...

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to 14 US-based companies for selling dozens of unapproved cancer treatments online and through social media. The companies, FDA says, have 15 days to respond with plans to address the violations or face possible criminal prosecution, including up to a year in federal prison and fine of $100,000 or twice the companies' gains on the fraudulent products. The agency is also advising patients ...

Although almost half of patients with cancer who are cured will have received radiation therapy as a component of their care, there is still a dearth of new therapies being developed in combination with radiation, officials from the US Food and Drug Administration (FDA) wrote in an article published this week. The authors, including Richard Pazdur, director of FDA's Oncology Center of Excellence, and FDA medical officer Amanda Walker, say that since 2006 there have been ...

A new bipartisan bill reintroduced in the House and Senate in late February, which could ultimately be attached to the reauthorized Prescription Drug User Fee Act (PDUFA), seeks to close the loopholes biopharmaceutical companies use to skirt around clinical trial requirements for cancer treatments in pediatric populations. Background Pediatric study requirements are included in both the Pediatric Research Equity Act (PREA), which requires biopharma companies to ...

More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature . Those expectations follow 2016 oncology approvals for FDA that included five new molecular entities and 17 ef...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will allow Roche’s atezolizumab to be used as part of an early access program for locally advanced or metastatic urothelial carcinoma. In terms of why the new treatment won a positive Early Access to Medicine Scientific (EAMS) opinion, MHRA said: “Atezolizumab has been shown to slow the progression of cancer and increase patient survival in a condition where other treatments currently h...

The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies. The effort, referred to as the NCI Formulary, is intended to streamline the negotiation process between investigators at NCI-designated cancer centers and participating pharmaceutical companies. "As genomic sequencing data become mainstream in cancer therapy...

The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding. The 996-page bill, known as the 21st Century Cures bill  and released last Friday, has already earned praise from the White House and is likely to pass the Senate, which will take it up early next week. In addition to speeding up the approvals of new drugs, devices...

Sanofi Pasteur said it’s discontinuing the manufacture of TheraCys, an important bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC). Benjamin Davies, MD, an associate professor of urology at the University of Pittsburgh School Of Medicine, writing in Forbes on Thursday, called on the government t...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Committee Pressures Commission to Create Europe-Wide Drug Pricing Initiatives The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) has called for continent-wide initiatives to improve access to medicines. In a draft report, ENVI takes the biopharma industry to task for prioritizing profits, not patients, when making research d...

In a new report on non-small cell lung cancer (NSCLC) treatments, the Institute for Clinical and Economic Review (ICER) found that for PD-1 immunotherapies, which are also often used to treat melanoma, the cost may be too high in terms of lengthening progression-free and overall survival. PD-1 immunotherapies target the checkpoint signaling pathway involving the programmed death 1 (PD-1) receptor, which can help protect tumor cells from being destroyed by the immune syst...