Oncology

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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).

The group, led by Koch Institute director Tyler Jacks, used CRISPR to generate mutant genes that were then packaged into enteroviruses that were used to infect target organs in mice. This is a much faster process than the traditional method that need crossing genetically-engineered mice.

Taiho Oncology, Inc, announced that the FDA granted Fast Track designation for an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer.

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