Many people with serious or life-threatening illnesses for which there are no satisfactory treatments are understandably eager to gain access to new therapies and are willing to trade off greater certainty about a drug’s performance for speed of access. Because the typical clinical drug-development program takes about 7 years, during which a substantial body of…
The FDA has come through with an early approval of the BTK drug ibrutinib, a likely new cancer blockbuster from Pharmacyclics ($PCYC) and Johnson & Johnson ($JNJ). The agency cut months off the traditional timeline for the drug, marking another quick OK for a “breakthrough” drugs, following the approval of Roche’s ($RHHBY) Gazyva two weeks ago.…
The 72-year-old man had tried every approved drug option available to treat the advanced kidney cancer that had spread throughout his body. As a last resort, he signed up for the first clinical trial of nivolumab, an experimental drug from Medarex and Bristol-Myers Squibb (BMS) that inhibits a protein called programmed death-1 (PD-1), which has…
This morning at a meeting in Washington, D.C., researchers from the academia, the Food and Drug Administration, the National Cancer Institute, a leading patient advocacy group and several drug companies are describing a new clinical trial in lung cancer that could fundamentally change the way cancer drugs are studied and approved, speeding medicines that target specific…
Speakers here at the Association of American Cancer Institutes (AACI)/Cancer Center Administrators Forum Annual Meeting discussed the escalating costs of cancer care and what can be done to keep high-quality care affordable. According to a new report on the crisis in cancer care from the Institute of Medicine (OT 10/10/13), the cost of cancer care…
FDA Friday (Nov. 1) approved a therapeutic combination that more than doubled progression free survival in patients — the first approval under the breakthrough drug designation created more than a year ago with the passage of the FDA Safety and Innovation Act. The agency approved Genentech’s Gazyva for use in combination with chlorambucil to treat…
Roche Holding AG (ROG) won approval for its Gazyva drug for patients with leukemia who haven’t been treated before. The medicine, also known as obinutuzumab, is cleared to treat chronic lymphocytic leukemia and is the first breakthrough therapy ever to receive approval, the Food and Drug Administration said today in a statement. The FDA granted…
ASCO today announced its second “Top Five” list of opportunities to improve the quality and value of cancer care. Published in the Journal of Clinical Oncology (JCO), ASCO’s second Top Five list was released as part of the Choosing Wisely® campaign, sponsored by the ABIM Foundation, to encourage conversations between physicians and patients aimed at curbing the use of certain…
How can we work together to achieve a future in which we’re beating cancer by providing care that is effective, affordable, high quality and patient-centered? Ellen Sigal: The key to beating cancer will be found through true collaboration from all sectors. For years, Friends of Cancer Research has convened the best and the brightest from all…
IBM continues to expand the use of its Watson supercomputer from winning Jeopardy to handling incoming call-center questions to guiding cancer doctorsat Memorial Sloan Kettering to better diagnoses. Today it announced a new pilot program for Watson at Houston’s renowned MD Anderson Cancer Center. The institution has been trying out Watson for a little under a year in its leukemia…
