CMS Blinks in ‘Flap’ Flap; Biomarker Testing; ‘What If’ Moment in Cancer Screening

Facing backlash from doctors, patients, and advocacy groups, the Centers for Medicare & Medicaid Services (CMS) has backed down from a proposal that would have reduced reimbursement for a type of breast reconstruction procedure and potentially limited breast cancer patients’ options for reconstruction. (KFF Health News)

Short-term use of immunosuppressants to treat an inflammatory condition did not increase the risk of cancer. (University of Pittsburgh)

Monitoring pubertal testicular function may help identify childhood cancer survivors who have a reduced likelihood of paternity. (Cancer)

Oncopeptides elaborates on its appeal of the FDA request for voluntary withdrawal of the multiple myeloma drug melphalan flufenamide (Pepaxto) from the U.S. market.

Exelixis and Ipsen announced that a phase III trial of cabozantinib (Cabometyx) and atezolizumab (Tecentriq) met the primary endpoint of improved progression-free survival in metastatic castration-resistant prostate cancer and showed a trend toward better overall survival.

A phase III clinical trial showed that selpercatinib (Retevmo) improved progression-free survival in RET-mutant medullary thyroid cancer as compared with cabozantinib or vandetanib (Caprelsa), Lilly announced.

The Justice Department announced that a Florida oncologist pleaded guilty to violating the Sherman Antitrust Act by conspiring to allocate chemotherapy and radiation therapy services.

Experts and even the FDA itself have expressed reservations about an FDA pilot program to evaluate the risks of approving a targeted cancer therapy without a companion diagnostic test. (BioSpace)

Meanwhile, a new analysis of cancer drug development suggests that targeted therapies developed with the aid of a companion diagnostic test could save $1 billion in R&D costs, though that might not trickle down to payers and patients. (King’s College London)

Preclinical studies showed that the combination of immunotherapy and a KRAS inhibitor produced “durable tumor elimination” in models of pancreatic cancer. (University of Texas MD Anderson Cancer Center)

Gilead Sciences announced that the FDA has placed a partial clinical hold on U.S. clinical trials of magrolimab for acute myeloid leukemia

While Fulcrum Therapeutics announced that the FDA has lifted a clinical hold on FTX-6058, an investigational therapy for sickle cell disease.

Merck and Eisai announced termination of a clinical trial of pembrolizumab (Keytruda) and lenvatinib (Lenvima) in advanced head and neck cancer after an interim analysis showed the study was unlikely to show a survival benefit versus pembrolizumab and placebo.

The FDA’s Oncologic Drugs Advisory Committee will meet October 5 to consider converting sotorasib’s (Lumakras) accelerated approval to full approval for KRAS-positive non-small cell lung cancer, Amgen announced.

An author reflects on a “what if” moment about current recommendations for lung cancer screening and his wife’s death from the disease. (CNN)

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