Shelf Life for Accelerated Approvals; CRC Tall Tale; Survivorship: Who’s in Charge?

Legislation introduced by Rep. Frank Pallone (D-N.J.) would give the FDA authority to set an expiration date on accelerated approvals. (Regulatory Affairs Professionals Society)

Immune checkpoint inhibitors developed in China will have to overcome major obstacles to gain a market foothold in Western nations. (GlobalData)

Merck announced that adjuvant pembrolizumab (Keytruda) significantly improved distant metastasis-free survival in melanoma in the phase III, placebo-controlled KEYNOTE-716 trial.

Gilead Sciences announced that the phase III TROPiCS-02 trial met the primary endpoint of improved progression-free survival with the antibody-drug conjugate sacituzumab govitecan (Trodelvy) in previously treated metastatic hormone receptor-positive breast cancer.

The FDA has placed a partial hold on the NEON-2 clinical trial of davoceticept-pembrolizumab combination therapy for advanced cancers following a fatal (grade 5) adverse event, Alpine Immune Sciences reported.

Taller adults may have a higher risk of colorectal cancer. (Johns Hopkins Medicine, Cancer Epidemiology, Biomarkers & Prevention)

Should cancer specialists or primary care physicians and nurses take the lead in cancer survivorship programs? (Oncology Business Review)

In a comment letter to CMS, the Community Oncology Alliance encouraged the agency to adopt a hard-line approach to pharmacy benefit manager fees.

Although rates of smoking have declined dramatically, rates among people in underserved communities remain twice the national rate. (Cancer)

David Penberthy, MD, MBA, of Bon Secours Southside Regional Medical Center in Petersburg, Virginia, has begun his term as president of the Association of Community Cancer Centers.

Frailty in older adults with cancer significantly increases the risk of postoperative mortality. (Annals of Surgical Oncology)

NuCana announced discontinuation of the phase III NuTide:121 trial of NUC-1031 (fosgemcitabine palabenamide) plus cisplatin after a planned futility analysis showed the trial would not meet the primary endpoint of overall survival in advanced biliary tract cancer.

The decline in HPV-related cervical cancer may have stalled and possibly made a 180° turn. (UTHealth Houston, JNCI Cancer Spectrum)

First dogs, now ants can sniff out cancer? (CNRS)