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Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
The FDA has granted priority review to the supplemental biologics license application seeking approval to expand the indication of lisocabtagene maraleucel to include patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had prior exposure to a BTK inhibitor and a BCL-2 inhibitor.
The combination of inetetamab, pertuzumab, paclitaxel, and carboplatin elicited responses with an acceptable safety profile when administered as neoadjuvant treatment in patients with locally advanced HER2-positive breast cancer.
CMG901 induced responses with a manageable toxicity profile in patients with CLDN18.2-positive gastric or gastroesophageal junction cancer, according to updated data from the dose-expansion phase of the phase 1 KYM901 study.
Treatment with vic-trastuzumab duocarmazine demonstrated a trend toward numerically prolonged overall survival compared with physician’s choice of treatment in patients with pretreated HER2-positive metastatic breast cancer.
The combination of garsorasib and cetuximab elicited responses and was found to be well tolerated in heavily pretreated patients with KRAS G12C–mutated colorectal cancer.
The Claudin-6–directed CAR T-cell therapy, BNT211, showed signs of clinical activity in patients with CLDN6-positive relapsed or refractory solid tumors.
The addition of atezolizumab to bevacizumab and chemotherapy resulted in a significant improvement in progression-free survival and overall survival vs standard treatment with bevacizumab and chemotherapy in patients with metastatic, persistent, or recurrent cervical cancer.
The FDA has approved pembrolizumab (Keytruda) plus gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
The FDA has granted breakthrough therapy designation to furmonertinib for use as a potential therapeutic option in patients with previously untreated, locally advanced or metastatic nonsquamous non–small cell lung cancer harboring EGFR exon 20 insertion mutations.
The addition of dostarlimab to carboplatin plus paclitaxel followed by dostarlimab monotherapy significantly improved overall survival compared with placebo plus chemotherapy followed by placebo in adult patients with primary advanced or recurrent endometrial cancer.
The combination of ibrutinib and bortezomib elicited durable responses in patients with relapsed or refractory mantle cell lymphoma and high-risk features such as a Ki-67 over 30%, blastoid or pleomorphic variant, p53 overexpression, and TP53 mutations and/or deletions.
Datopotamab deruxtecan elicited encouraging responses in patients with heavily pretreated non–small cell lung cancer harboring actionable genomic alterations.
Vepdegestrant continued to showcase clinical activity with favorable tolerability spanning all doses examined in heavily pretreated patients with estrogen receptor–positive, HER2-negative advanced breast cancer, according to updated dose-escalation data from a phase 1/2 study.
The FDA has approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes with a susceptible IDH1 mutation, as detected by an FDA-approved test.
Selpercatinib (Retevmo) showcased superior efficacy, with improved progression-free survival, vs chemotherapy with or without pembrolizumab in the first-line treatment of patients with RET fusion–positive non–small cell lung cancer.
The FDA has granted accelerated approval to entrectinib (Rozlytrek) for pediatric patients aged older than 1 month with solid tumors that harbor a NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed after treatment or have no satisfactory standard therapy options.
Dostarlimab plus chemotherapy elicited a higher objective response rate and showcased a numerical improvement in overall survival compared with pembrolizumab and chemotherapy in patients with treatment-naïve, nonsquamous non–small cell lung cancer.
The 2023 ESMO Congress, which is taking place in Madrid, Spain, and will continue to be accessible online via a virtual platform, is gearing up to kick off, and the oncology community is ready to learn more about the latest data across malignancies.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the approval of a Type II variation application for rucaparib as a frontline maintenance in patients with advanced ovarian cancer who have responded to first-line, platinum-based chemotherapy, irrespective of BRCA mutational status.
The FDA has approved pembrolizumab (Keytruda) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of pembrolizumab monotherapy as post-surgical adjuvant treatment for patients with resectable non–small cell lung cancer.
Lirafugratinib demonstrated clinical activity in multiple subsets of patients with FGFR2-altered solid tumors, including those with FGFR2-altered hormone receptor–positive, HER2-negative breast cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib in combination with obinutuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 lines of systemic treatment.
The FDA has approved encorafenib (Braftovi) plus binimetinib (Mektovi) for adult patients with metastatic non–small cell lung cancer harboring a BRAF V600E mutation, as detected by an FDA-approved test.
The addition of bexmarilimab to standard-of-care azacitidine or azacitidine plus venetoclax continued to elicit responses in patients with relapsed or refractory acute myeloid leukemia and those with myelodysplastic syndrome who were refractory to hypomethylating agents.
TJ-L14B/ABL503 demonstrated preliminary efficacy signals in the form of responses in patients with progressive, locally advanced or metastatic solid tumors who were relapsed or refractory after previous lines of therapy.
Pembrolizumab plus chemotherapy prior to surgery, followed by resection and single-agent pembrolizumab in the adjuvant setting, significantly improved overall survival vs neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in patients with resectable stage II, IIIA, or IIIB (T3-4N2) non–small cell lung cancer, meeting the dual primary end point of the phase 3 KEYNOTE-671 trial.
The undetectable minimal residual disease ate achieved with bendamustine followed by obinutuzumab, acalabrutinib, and venetoclax increased as the regimen was continued as maintenance treatment in patients with relapsed or refractory chronic lymphocytic leukemia.
The combination of venetoclax and dexamethasone failed to significantly improve progression-free survival over pomalidomide plus dexamethasone in patients with t(11;14)-positive, relapsed or refractory multiple myeloma who have previously received at least 2 therapies.
A Type II extension of indication application seeking the approval of amivantamab in combination with carboplatin and pemetrexed for the frontline treatment of adult patients with advanced non–small cell lung cancer and activating EGFR exon 20 insertion mutations has been submitted to the European Medicines Agency.
The biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, a biosimilar of pegfilgrastim, has been resubmitted to the FDA for review.
