Biomarker-Driven Lung Cancer

A look back at all the FDA news that occurred in July.

ALK-Translocated Non-Small Cell Lung Cancer With Bone Metastases

During the 2017 ESMO Congress, to be held September 8-12 in Madrid, Spain, the European Society for Medical Oncology (ESMO) will award 4 oncologists with its distinguished annual awards:

Durvalumab (Imfinzi) has been granted a breakthrough therapy designation by the FDA to treat patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation.

Progression-free survival (PFS) was not improved with frontline durvalumab (Imfinzi), either in combination with tremelimumab or as a single agent, in patients with stage IV metastatic non–small cell lung cancer (NSCLC), compared with standard platinum-based chemotherapy.

Supplemental Biologics License Applications (sBLAs) were sent to and accepted by the FDA for a new dosing schedule for nivolumab (Opdivo) across all of the agent's indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor. 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given its support on indications for atezolizumab (Tecentriq) in non–small cell lung cancer (NSCLC) and urothelial carcinoma. 

Treatment of BRAF Mutated Non-Small Cell Lung Cancer

Treatment of ALK+ Non-Small Cell Lung Cancer

In a 17-0 vote, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of ABP-215, a biosimilar for bevacizumab.

Martin Gutierrez, MD, director, drug discovery/phase I unit, medical oncologist, thoracic and gastrointestinal oncology, John Theurer Cancer Center, discusses results for durvalumab (Imfinzi) for the treatment of non-small cell lung cancer.

Matthew D. Hellmann, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the CheckMate-032 study, which explored nivolumab (Opdivo) with or without ipilimumab (Yervoy) for patients with small cell lung cancer (SCLC).

A look back at all the FDA news that happened in the month of June, including in multiple myeloma, hematology, sarcoma, and lung cancer.

Solange Peters, MD, PhD, has been elected the president of the European Society for Medical Oncology (ESMO) for the 2020-2021 term.

Ceritinib has been approved by the European Union (EU)&nbsp;for the first-line treatment of patients with <em>ALK</em>-positive advanced non&shy;&ndash;small cell lung cancer.