Oncology

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The study by Andrew Mulcahy, a policy researcher at the RAND Corporation, found that the predicted $44 billion saving to the US healthcare system over the next decade, would depend on FDA decisions on newer biosimilar drug candidates.

The guideline, published in the Canadian Medical Association Journal, recommends against using PSA to screen for prostate cancer, pointing to the high risk of false positives and overdiagnosis.

The retrospective study, results of which were presented at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology, showed that the total diagnostic workup cost for the study sample of Medicare beneficiaries was $38.3 million.

While the USPSTF recommended against screening for prostate cancer, citing the high rate of false positives, complications from biopsy, and side-effects of aggressive treatment for a sometimes slowly-progressing disease, several medical organizations disagree.

The war of words between managed care and pharmaceutical manufacturers, which began when Gilead set the price for its drug to treat the hepatitis C virus (HCV), has taken off in October with the reclassification of a trio of cancer drugs from Genentech. Growth in the "specialty pharma" sector, where prices are rising much faster than drug prices generally, has drawn concern from payers and the umbrella group that represents them, while the trade group that represents drugmakers is pushing back against critics, saying that it faces challenges in bringing life-saving therapies to market.

Recently approved as second-line treatment of metastatic melanoma, following resistance to ipilimumab, the FDA has now designated Keytruda as breakthrough therapy to treat EGFR-mutation and ALK-rearrangement negative NSCLC patients who have pr0gressed following platinum-based therapy.

Today, Merck announced that Keytruda has been granted breakthrough therapy designation for treating patients with epidermal growth factor receptor mutation-negative and anaplastic lymphoma kinase rearrangement-negative non-small cell lung cancer (NSCLC).

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