KADCYLA® (Ado-Trastuzumab Emtansine, T-DM1) now approved

February 22nd, 2013

The FDA today approved KADCYLA® for the treatment of patients  with HER2-positive metastatic breast cancer who have received prior treatment with HERCEPTIN® (Trastuzumab) and a taxane chemotherapy. In a large Phase III trial, KADCYLA® improved Progression Free Survival as well as Overall Survival compared to XELODA® (Capecitabine) and TYKERB® (Lapatinib). KADCYLA® is the fourth drug approved by the FDA, that targets the HER2 oncogene. The other  FDA-approved drugs used to treat HER2-positive breast cancer include HERCEPTIN® (1998), TYKERB® (2007) and PERJETA® (Pertuzumab) (2012).

Vitamin D deficiency and Bladder Cancer

February 17th, 2013

The active metabolite of Vitamin D is Vitamin D3. In a recent study published in the JNCI, September 2012 issue, the authors noted a statistically significant increase in the risk of Bladder Cancer in individuals with low plasma concentrations of Vitamin D3. It is felt that Vitamin D3 favorably upregulates Fibroblast Growth Factor Receptor 3 (FGFR3). Mutations in FGFR3 are known to be associated with urothelial carcinoma. Urine samples evaluating for FGFR3 mutations, to diagnose urothelial carcinoma, has a positive predictive value of 95% when detected in patients with no history of Bladder Cancer. It appears that patients with aggressive bladder cancer have low expression of wild- type FGFR3 in association with low plasma concentrations of Vitamin D3. Therefore, it is possible that low plasma concentrations of Vitamin D3 may predict increased risk for bladder cancer, with more aggressive types of bladder cancer manifesting in those with significantly low Vitamin D3 levels.


February 10th, 2013

PBRT is a type of external beam radiation therapy in which a beam of Proton particles are used to irradiate cancer tissue. It has been claimed that the main advantage of proton therapy is its ability to more precisely localize the radiation dosage to the tumor tissue and thereby improve tumor control, without causing significant damage to the surrounding tissues. This theoretical consideration was however disproved in a study published in the Jan 2, 2013 issue of the JNCI. In this study, data was gathered following prostate cancer treatment of over 22,000 medicare beneficiaries, with either IMRT (Intensity Modulated Radiation Therapy) or PBRT. The authors noted that PBRT was not superior to IMRT with regards to efficacy or toxicity, after one year. PBRT was however twice as expensive as IMRT. It therefore remains to be seen if third party payors will warm up to PBRT,  with the expansion of PBRT centers across the country.