The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Frontline Osimertinib Approved in China for EGFR+ NSCLC
September 4th 2019China’s National Medical Products Administration has approved osimertinib for the frontline treatment of adult patients with locally-advanced or metastatic non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 (L858R) substitutions.
Encorafenib/Binimetinib Combo Continues to Show Survival Benefit in BRAF-Mutant Melanoma
September 3rd 2019Encorafenib (Braftovi) plus binimetinib (Mektovi) had superior overall survival and progression-free survival compared with encorafenib or vemurafenib (Zelboraf) alone in patients with BRAF V600–mutant melanoma.
FDA Delays Decision on Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel in Nonsquamous NSCLC
August 31st 2019The FDA has extended the review period for a supplemental biologics license application for atezolizumab for use in combination with carboplatin and nab-paclitaxel as a first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer who do not have EGFR or ALK aberrations.
Ilixadencel Plus Sunitinib Induces Complete Responses in Metastatic RCC
August 29th 2019The combination of the off-the-shelf cancer immune primer ilixadencel and sunitinib elicited a 11% complete response rate in patients with metastatic renal cell carcinoma, according to topline findings from the phase II MERECA trial (NCT02432846).
Data Show Potential Impact of Shared Decision Making With RAI Therapy in Thyroid Cancer
August 29th 2019Patients with differentiated thyroid cancer who were felt to not have a choice in receiving radioactive iodine treatment reportedly had lower satisfaction with the treatment decision, suggesting a need for increased shared decision making between physicians and patients.
Atezolizumab Plus Nab-Paclitaxel Approved in Europe for Frontline TNBC
August 29th 2019The European Commission has approved the frontline combination of atezolizumab plus nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer, according to Roche (Genentech), the manufacturer of the PD-L1 inhibitor.
Elotuzumab Triplet Approved in Europe for Multiple Myeloma
August 28th 2019The European Commission has approved elotuzumab for use in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.