The White House moonshot to accelerate progress in cancer research directs FDA to consolidate its oncology portfolio. However, oncology insiders say the manner in which the presidential initiative will be implemented could make the difference between political balderdash and genuine improvement in FDA regulation of cancer therapies. The entire controversy boils down to the interpretation…
The Food and Drug Administration intends to move forward with plans to partner officials in different agency centers with expertise in products affecting cancer in an effort to streamline the review process. President Barack Obama’s proposed fiscal year 2017 budget includes a request for $75 million as part of Vice President Joseph R. Biden Jr.’s…
Targeted immunotherapies have added an important new treatment approach to oncologists’ armamentarium, especially for melanoma, lung cancer, and blood cancers. Cancer immunotherapy is considered such an exciting area that the American Society of Clinical Oncology (ASCO) chose this field as its cancer advance of the year for 2016. But many challenges remain in bringing treatments…
Cancer patients have traditionally been treated based on where their tumors originate — lung tumors with treatments for lung cancer, breast tumors with therapies developed specifically for breast cancer. But what if doctors started caring less about where a tumor first emerged and more about the genetic mutations that caused it to appear in the…
“In order to take advantage of today’s advancements in science, drug development, and patient treatment, the U.S. Food and Drug Administration’s (FDA’s) structure needs reorganization to focus its resources and ensure the best outcomes for patients. Friends of Cancer Research (Friends) proposes enhancing coordination at the FDA based on specific disease areas, rather than approving…
Executive Summary Products like Amgen’s viral therapy for melanoma could benefit under proposals to replace FDA’s modality-based organization with disease-specific centers. FDA’s biologics center proved itself capable of reviewing the oncologic, but the drugs center already had extensive recent experience with the fast-changing melanoma market. The FDA review of Amgen Inc.’s Imlygic could provide support…
Executive Summary Commissioner Califf says review staff reorganization based on disease will go ahead regardless of what other headway VP Biden’s initiative makes. Oncology product regulation at FDA will be reorganized no matter what happens with VP Joe Biden’s Cancer Moonshot. The White House initiative intended to boost efforts to find a cure for cancer…
Today is a new day for cancer research, with the introduction of transformational immune-based therapies that have the potential to change patients’ lives. Such potential means that everyone must innovatively collaborate on ways to speed the drug development and regulatory process so that potentially life-saving therapies reach patients with the greatest urgency, many of whom…
The FDA’s breakthrough therapy designation has led to shorter drug development times and shorter FDA review times, industry experts said April 12 during a Senate briefing. Enacted in July 2012 as part of the Food and Drug Administration Safety and Innovation Act (Pub. L. No. 112-144), the breakthrough therapy designation expedites the development and review…
THE POWER OF COLLABORATION Friends Annual Meeting We are proud to host our yearly Annual Meeting with support from the American Association for Cancer Research, American Society of Clinical Oncology, and Susan G. Komen to address critical issues in the development of new oncology drugs. As of 2016, the Conference on Clinical Cancer Research has become the Friends Annual…
