Articles

On November 5, 2019, the FDA approved pegfilgrastim-bmez (Ziextenzo; Sandoz) as a third biosimilar to Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor. The previous 2 biosimilars to Neulasta were approved in 2018.

On November 14, 2019, the FDA granted accelerated approval to zanubrutinib capsules (Brukinsa; BeiGene), a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of adults with mantle-cell lymphoma who have received at least 1 previous therapy.

Barcelona, Spain—Results of the new clinical trial RADICALS-RT indicate that using salvage radiotherapy immediately after surgery leads to equivalent outcomes in terms of progression-free survival (PFS) versus adjuvant radiotherapy in men with prostate cancer undergoing radical prostatectomy.

Barcelona, Spain—The poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza) delayed disease progression and showed a trend toward improved survival compared with newer hormonal agents in men with pretreated metastatic castrate-resistant prostate cancer (CRPC) and homologous recombinant repair (HRR) gene mutations or with BRCA1, BRCA2, and ATM mutations. Results of this late-breaker were reported at the ESMO Congress 2019 during the presidential session.

Barcelona, Spain—Treatment with ceritinib (Zykadia) led to excellent responses in patients with ALK-positive non–small-cell lung cancer (NSCLC) and brain metastases, according to results of the ASCEND-7 clinical trial, which enrolled only patients with ALK-positive NSCLC with newly diagnosed or progressive brain metastases.

San Francisco, CA—Keeping up with the many treatment advances in relapsed or refractory multiple myeloma can be a challenge for even the most informed providers, according to Jorge J. Castillo, MD, Clinical Director, Bing Center for Waldenström’s Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA.

San Francisco, CA—Steroids plus exercise could be the best combination for treating fatigue in patients with advanced cancer, according to data presented at the 2019 Supportive Care in Oncology Symposium.

Barcelona, Spain—Poly (ADP-ribose) polymerase (PARP) inhibition has an established role as maintenance therapy in women with newly diagnosed high-grade advanced ovarian cancer and a BRCA mutation. At the ESMO Congress 2019, results of 3 clinical trials expand the use of PARP inhibition in ovarian cancer to all patients.

New York, NY—With cancer drugs representing some of the most expensive pharmaceuticals on the market, conversations abound around value in oncology and proposed solutions for achieving it. At the 2019 AVBCC Summit, experts on the topic of drug pricing hashed out which frameworks are best suited for real-world applications in cancer care.

On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers.