Caroline Seymour

The FDA has granted priority review to a supplemental biologics license application for enfortumab vedotin plus pembrolizumab for the frontline treatment of patients with locally advanced or metastatic urothelial cancer.

The FDA has granted fast track designation to zotatifin for use in combination with fulvestrant and abemaciclib as second- or third-line therapy for the treatment of patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer with disease progression following treatment with endocrine therapy and a CDK4/6 inhibitor.

Nadofaragene firadenovec-vncg led to encouraging rates of high-grade recurrence-free survival and overall survival in patients with high-risk, BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

Telisotuzumab vedotin produced meaningful response rates and other clinically relevant outcomes in patients with c-Met protein overexpressed, EGFR wild-type, advanced or metastatic nonsquamous non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer

Although not immediately practice changing, CAR T-cell therapy has the potential to become a standard of care for patients with advanced renal cell carcinoma following progression on checkpoint inhibitors and VEGF inhibitors.

Improvements in screening, systemic therapy, and precision medicine have reduced breast cancer mortality and morbidity, and further progress will hinge on the use of ctDNA and CTCs for disease monitoring, continued development of novel antiestrogenic agents, and movement of ADCs and immunotherapy into expanded settings and indications.

The FDA has updated the current indication for pembrolizumab plus trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma to those whose tumors express PD-L1 with a CPS of 1 or more.

The addition of pyrotinib to trastuzumab and docetaxel led to a significant improvement in progression-free survival compared with placebo plus trastuzumab and docetaxel in patients with newly diagnosed, HER2-positive metastatic breast cancer.

Brexucabtagene autoleucel demonstrated an improvement in overall survival vs standard of care therapy in patients with relapsed/refractory mantle cell lymphoma following prior exposure to a BTK inhibitor, according to data from an indirect treatment comparison of findings from the phase 2 ZUMA-2 trial and retrospective SCHOLAR-2 trial.

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The combination of amivantamab and lazertinib reduced the risk of disease progression or death by 30% compared with osimertinib alone as frontline therapy for patients with advanced non–small cell lung cancer harboring classical EGFR sensitizing mutations.

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Tisotumab vedotin led to a 30% reduction in the risk of death vs investigator’s choice of chemotherapy as second- or third-line therapy in patients with recurrent or metastatic cervical cancer with disease progression on doublet chemotherapy.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ESMO Congress. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

The combination of amivantamab-vmjw (Rybrevant) and chemotherapy produced a median progression-free survival of 11.4 months vs 6.7 months with chemotherapy alone in patients with advanced, EGFR exon 20 insertion–positive non–small cell lung cancer.

Sacituzumab govitecan-hziy led to modest but durable antitumor activity with predominant gastrointestinal toxicities in patients with metastatic or locally recurrent head and neck squamous cell carcinoma who received between 1 and 3 prior lines of therapy.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ESMO Congress. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

The European Medicines Agency’s Committee for Orphan Medical Products has granted orphan drug designation to LSTA1 for the treatment of patients with pancreatic cancer.

The European Commission has approved pembrolizumab as adjuvant monotherapy for the treatment of adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

Treatment with single-agent venetoclax led to prolonged disease response in patients with chronic lymphocytic leukemia who had relapsed or become refractory to prior B-cell receptor inhibitors including ibrutinib and idelalisib, according to findings from a phase 2 study.

Stable peripheral disease levels lasting 12 months were reported in patients with treatment-naïve chronic lymphocytic leukemia following 6 years of continuous treatment with ibrutinib.

Treatment with the first-in-class radioenhancer NBTXR3 proved tolerable and effective in older patients with advanced head and neck squamous cell carcinoma and a comorbidity index.

Pembrolizumab as adjuvant therapy led to a statistically significant and clinically meaningful improvement in disease-free survival compared with observation in patients with localized muscle invasive urothelial cancer and locally advanced urothelial cancer.

The European Commission has granted marketing authorization for Enrylaze for use as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month and older who developed hypersensitivity or silent inactivation to E. coli–derived asparaginase.

The FDA has granted orphan drug designation to the next generation BCMA-directed CAR T-cell therapy NXC-201 for the treatment of patients with amyloid light chain amyloidosis.

The European Commission has approved elacestrant for the treatment of postmenopausal women and men with estrogen receptor–positive, HER2-negative, locally advanced, or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least 1 line of endocrine therapy including a CDK4/6 inhibitor.

The Committee for Medicinal Products for Human Use has recommended the approval of quizartinib in the European Union for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by maintenance quizartinib, for adult patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

Tissue- and blood-based molecular analysis could help match patients with advanced hepatocellular carcinoma or hepatocholangiocarcinoma following disease progression on frontline atezolizumab and bevacizumab to targeted therapy or another TKI based on identified genomic alterations.

The National Institute for Health and Care Excellence has published its Final Draft Guidance recommending the use of ruxolitinib as treatment for eligible patients in England and Wales with polycythemia vera that is resistant or intolerant to hydroxycarbamide/hydroxyurea.