Surgeons may now have a better tool for tracking where tumors have spread, according to a phase III clinical trial that was reported in the Annals of Surgical Oncology. Tumors can spread into nearby (or sentinel) lymph nodes; the new tool is a radioactive dye called tilmanocept that marks lymph nodes. The trial included 148 people with both melanoma and breast cancer. The researchers found that tilmanocept identified nearly 20% more tumor cells in sentinel lymph nodes than the standard blue dye (94% vs 76%). Tilmanocept, which is also called Lymphoseek, was approved by the FDA on March 13, 2013.
“Four new therapies have been recently approved for the treatment of men with castration-resistant prostate cancer; still, more treatment options are needed. This review summarizes the data supporting a role for novel chemotherapies including epothilones and immunomodulators (IMiDs), as well as other novel agents within the new landscape of approved therapies.”
“The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.”
Advanced prostate cancer patients used to be treated with palliative chemotherapy that did not improve survival. But in the past decade, researchers have introduced several new therapies for castration-resistant prostate cancer (CRPC) and related complications. These drugs include cabazitaxel (Jevtana), abiraterone acetate (Zytiga), enzalutamide (Xtandi), sipuleucel-T (Provenge), radium-223, and denosumab (Xgeva or Prolia). Two researchers recently performed a cost-benefit analysis on these new therapies. They say that costs will come down as treatment strategies—including precisely timed combinations of drugs—are refined to minimize progression and side effects.
Three percent to 5% of non-small cell lung cancer (NSCLC) patients have a mutation in the ALK gene and may benefit from treatment with critozinib (Xalkori). In 2011, the FDA approved a test that samples NSCLC tissue and highlights ALK mutations with a glowing tag. Now, the FDA has approved an automated scanning system, GenASIs Scan & Analysis, for examining these tagged tissue samples. The automated system, produced by Applied Spectral Imaging, promises fast, reliable detection of ALK mutations in NSCLC.
In April of 2010, the Food and Drug Administration (FDA) approved the first immunotherapy for prostate cancer. Sipuleucel-T (Provenge), an autologous active cellular immunotherapy (a cancer vaccine), was approved for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Sipuleucel-T was also the first active cellular immunotherapy approved by the FDA and, at the time of approval, only the second approved drug for mCRPC patients. Prior to approval, the only other option for these patients was the chemotherapy docetaxel. Continue reading…
Radium Ra 223 Dichloride will be considered as a treatment for patients who have castration-resistant prostate cancer with bone metastases under the FDA’s priority review program. The filing is based on the 922 patient phase III ALSYMPCA trial, of radium-223 plus current standard of care, or placebo plus current standard of care.
The recent approval by the U.S. Food and Drug Administration (FDA) for the production of C-11 choline at Mayo Clinic for PET imaging in patients with biochemical recurrence (BCR) of prostate cancer has generated intense interest in the biomedical molecular imaging community. The main reason for this enthusiasm is that this is the first approval of a PET agent specifically for detecting sites of recurrence in prostate cancer, a highly prevalent disease for which conventional imaging tools have proven inadequate.