Drs. Geoffrey Oxnard and Lauren Ritterhouse discuss the challenges in biomarker testing—tissue stewardship and complexity of biomarker tests and results—and ways to overcome these challenges—improved communication among all members of the cancer care team and simplification of biomarker test results to focus on actionable biomarkers.
On April 28, 2017, the FDA accelerated the approval of brigatinib (Alunbrig; Takeda Oncology), a new-generation oral ALK inhibitor, for the treatment of patients with ALK-positive metastatic NSCLC who do not tolerate or have had an inadequate response to crizotinib.
On October 31, 2017, the FDA granted an accelerated approval for acalabrutinib (Calquence; AstraZeneca), an oral BTK inhibitor, for the treatment of adults with mantle-cell lymphoma who have received at least 1 therapy.
On January 19, 2017, the FDA granted accelerated approval of a new indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with relapsed or refractory MZL who require systemic therapy after at least 1 anti-CD20–based therapy.
On May 1, 2017, the FDA granted accelerated approval to durvalumab (Imfinzi; AstraZeneca), an intravenous (IV) PD-L1 inhibitor, for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
On February 22, 2017, the US Food and Drug Administration (FDA) approved lenalidomide (Revlimid; Celgene), an oral IMiD, for maintenance therapy after autologous HSCT in patients with multiple myeloma.
On August 3, 2017, the FDA granted an accelerated approval for the new combination of daunorubicin and cytarabine liposome (Vyxeos; Jazz Pharmaceuticals), an intravenously infused drug, for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes.
Using its priority review process, on March 27, 2017, the FDA approved niraparib (Zejula; Tesaro), an oral PARP inhibitor, for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors have completely or partially responded to platinum-based chemotherapy.
As the costs associated with cancer care continue to escalate, all key stakeholders—healthcare providers, private and government payers, and patients—strive to balance high-quality cancer care with cost efficiency.