
The FDA has accepted a BLA seeking the approval of ivonescimab plus chemotherapy for EGFR-mutated, advanced, nonsquamous NSCLC after TKI progression.

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Associate Editor, OncLive
Ashling Wahner joined MJH Life Sciences in 2022. She produces OncLive's podcast, OncLive On Air, and helps ensure timely publication of news content and announcements from the FDA approval pipeline. She also attends conferences live and virtually to conduct video interviews and produce written coverage. Email: awahner@mjhlifesciences.com

The FDA has accepted a BLA seeking the approval of ivonescimab plus chemotherapy for EGFR-mutated, advanced, nonsquamous NSCLC after TKI progression.

The gremlin-1–directed monoclonal antibody ginisortamab showed early efficacy signals when combined with SOC therapy in patients with advanced GI tumors.

The FDA has approved daratumumab and hyaluronidase plus VRd for adult patients with newly diagnosed multiple myeloma who are not eligible for ASCT.

Treatment with first-line metronomic cyclophosphamide did not significantly improve TTF, PFS, or OS vs doxorubicin in advanced soft tissue sarcoma.

The NCCN Guidelines recognize that MammaPrint can help identify a subset of early-stage breast cancer likely to benefit from anthracycline-based therapy.

Phase 1 data demonstrate early safety and efficacy signals with targeting CBP/p300 in patients with solid tumors.

The combination of relacorilant and nab-paclitaxel generated an OS benefit vs nab-paclitaxel monotherapy in platinum-resistant ovarian cancer.

The INAVO123 trial is exploring frontline inavolisib plus a CDK4/6 inhibitor and letrozole in PIK3CA-mutant, hormone receptor–positive breast cancer.

Shaji Kumar, MD, discusses the mechanism of action of cevostamab, as well as data with a cevostamab-containing triplet in relapsed/refractory myeloma.

Lung cancer experts stress the importance of lung cancer screening and discuss ways that technological advances are transforming screening processes and outcomes.

Jonathan H. Sherman, MD, FAANS, FCNS, FACS, discusses innovations in brain surgery and the importance of balancing oncological and functional outcomes.

The FDA accepted and gave priority review to an NDA for gedatolisib in hormone receptor–positive, HER2-negative, PIK3CA wild-type advanced breast cancer.

Xiuning Le, MD, PhD, discusses the FDA approval of sevabertinib for pretreated, advanced, nonsquamous NSCLC with tumors harboring HER2 TKD mutations.

Lorenzo Falchi, MD, discusses the FDA approval of epcoritamab plus lenalidomide and rituximab for relapsed/refractory follicular lymphoma.

Treatment with nogapendekin alfa inbakicept plus BCG prolonged duration of complete response compared with BCG alone in patients with BCG-naive NMIBC.

Treatment with pembrolizumab after GI-6207 therapy did not generate therapeutic responses in patients with recurrent/metastatic medullary thyroid cancer.

Yue Wei, PhD, discussed the role of HMAs in platelet response in MDS and the clinical relevance of using a mouse model to investigate this approach.

Andrea Necchi, MD, dives into the details of the SunRISe-4 trial findings, implications, and ways that utDNA and ctDNA may operate as biomarkers in MIBC.

Andrew W. Hahn, MD, discusses the efficacy and safety of lenvatinib plus everolimus in metastatic ccRCC after progression on PD-1–directed ICIs

Jessica C. Hassel, MD, discusses the mechanism of action of the IO102-IO103 vaccine and the implications of its efficacy data in melanoma.

A target action date of August 30, 2026, has been set for the FDA's decision regarding the sBLA seeking the approval of ropeginterferon alfa-2b for ET.

Patients with relapsed/refractory MCL had poor treatment outcomes with BTK inhibition, which decreased in quality as the line of therapy advanced.

Nivolumab plus ipilimumab continued to yield an efficacy and safety benefit vs lenvatinib or sorafenib in previously untreated, unresectable HCC.

Brian Slomovitz, MD, discusses key trials and surgical advances for patients with ovarian cancer.

Zolbetuximab plus chemotherapy delivered maximal clinical benefits when AEs were managed effectively in CLDN18.2-positive advanced gastric/GEJ cancer.

Zolbetuximab plus mFOLFOX6 and nivolumab was effective and tolerable across biomarker-defined subgroups in unresectable gastric/GEJ adenocarcinoma.

The FDA has received a new drug application seeking the approval of rusfertide for the treatment of adult patients with polycythemia vera.

Jason Mouabbi, MD, discusses the emerging role of ctDNA tests in breast cancer management and their use in early detection and treatment monitoring.

The FDA has received a new drug application seeking the approval of bezuclastinib for the treatment of patients with non-advanced systemic mastocytosis.

In case you missed any, read a recap of every episode of OncLive On Air that aired in December 2025.

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