The Art of Oncology; Drug-Shortage Protests; Appeal for Accelerated Approvals

A mid-career oncologist reflects on the importance of the “art of oncology” in the midst of rapidly changing clinical science. (Journal of Clinical Oncology)

The combination of cabozantinib (Cabometyx) and nivolumab (Opdivo) produced tumor shrinkage that allowed 12 of 15 patients with unresectable liver cancer to undergo surgery. (Johns Hopkins Medicine, Nature Cancer)

Servier announced that adding the IDH1 inhibitor ivosidenib (Tibsovo) to azacitidine significantly improved event-free and overall survival in a phase III trial of untreated IDH1-mutated acute myeloid leukemia.

An Illinois jury found Johnson & Johnson not liable for a woman’s death from ovarian cancer, which her family had blamed on use of the company’s talcum powder. (Reuters)

Thousands of cancer survivors, along with their families and friends, marched in the streets of Mexico City to protest ongoing shortages of cancer medications across the country. (Lancet Oncology)

Merck announced that adjuvant pembrolizumab (Keytruda) significantly improved recurrence-free survival in a placebo-controlled trial of resected high-risk melanoma.

BeyondSpring Pharmaceuticals announced that adding the immunomodulatory microtubule inhibitor plinabulin to docetaxel led to significant improvement in overall survival versus docetaxel alone as second- or third-line treatment for EGFR wild-type non-small cell lung cancer (NSCLC).

A phase III trial of untreated advanced NSCLC ended early after data showed significant improvement in overall survival with the addition of cemiplimab (Libtayo) to chemotherapy, Regeneron announced.

Bristol Myers Squibb announced voluntary withdrawal of accelerated approval of romidepsin (Istodax) for previously treated peripheral T-cell lymphoma, after a confirmatory phase III clinical trial failed to produce sufficient clinical benefit.

China-based BeiGene, which has rapidly expanded into the oncology field, announced plans for a 42-acre research and development campus in New Jersey, where it will add “hundreds” of new jobs.

BeiGene also announced that its Bruton tyrosine kinase inhibitor zanubrutinib (Brukinsa) significantly improved progression-free survival in untreated chronic lymphocytic leukemia as compared with bendamustine and rituximab (Rituxan).

A fourth of patients with previously treated metastatic HER2-positive biliary cancer responded to the dual anti-HER2 combination of trastuzumab (Herceptin) and pertuzumab (Perjeta). (Lancet Oncology)

A coalition of pharma companies that focus on rare diseases appealed to Congress to “preserve and strengthen” the FDA’s accelerated approval program, which has faced scrutiny over some recent oncology approvals, even more so following approval of the controversial Alzheimer’s drug aducanumab (Aduhelm).