Caroline Seymour

The FDA has placed a hold on the clinical program for the investigational new drug CART-ddBCMA for the treatment of patients with relapsed/refractory multiple myeloma.

The addition of ibrutinib to bendamustine plus rituximab or R-CHOP did not lead to a statistically significant improvement in progression-free survival vs either chemoimmunotherapy regimen alone in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma.

The European Medicines Agency has validated and accepted a marketing authorization application for priority review for fruquintinib for the treatment of adult patients with pretreated metastatic colorectal cancer.

Treatment with the JAK2 inhibitor pacritinib demonstrated comparable improvements in spleen and symptom response regardless of baseline platelet counts and hemoglobin levels, according to findings from the pivotal phase 3 PERSIST-1 and PERSIST-2 trials.

Treatment with duvelisib led to a high response rate in patients with peripheral T-cell lymphoma, with activity favoring patients with PTCL not otherwise specified and angioimmunoblastic T-cell lymphoma.

The FDA has approved a 505(b)(2) new drug application for Pemrydi RTU, the first and only ready-to-use presentation of pemetrexed or injection that does not require reconstitution, dilution, or refrigeration

The FDA has granted priority and standard review designations to the biologics license applications for exagamglogene autotemcel for the treatment of patients with sickle cell disease and transfusion-dependent beta thalassemia, respectively, marking the first CRISPR gene editing filings to be accepted for review by the FDA.

The FDA has accepted and granted priority review designation to the new drug application for the combination of capivasertib and fulvestrant for the treatment of patients with hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after endocrine-based therapy.

Rusfertide demonstrated freedom from phlebotomy, sustained hematocrit control, and 12-week treatment completion in 69.2% vs 18.5% of patients with phlebotomy-dependent polycythemia vera who received placebo, meeting the primary end point of the phase 2 REVIVE trial.

Treatment with pelabresib monotherapy led to a 60% confirmed complete or partial hematologic response at any time without incurring grade 4 or 5 treatment-related adverse effects in patients with high-risk essential thrombocythemia refractory or intolerant to hydroxyurea.

Acalabrutinib and zanubrutinib demonstrated similar investigator-assessed progression-free survival in patients with relapsed/refractory chronic lymphocytic leukemia.

Treatment with lisocabtagene maraleucel elicited encouraging responses regardless of prior progression on BTK inhibition or absence of clinical benefit with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, meeting the primary end point of the phase 1/2 TRANSCEND CLL 004 trial.

The combination of mRNA-4157 and pembrolizumab reduced the risk of developing distant metastasis or death by approximately 65% compared with pembrolizumab alone as adjuvant therapy in patients with resected melanoma at high risk of recurrence, according to findings from the phase 2 KEYNOTE-942 trial.

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

The addition of sintilimab to chemoradiotherapy demonstrated a significant reduction in the risk of disease recurrence or death, distant metastasis and locoregional recurrence compared with chemoradiotherapy alone as frontline therapy in patients with locally advanced nasopharyngeal carcinoma, according to findings from the phase 3 CONTINUUM trial.

Nivolumab plus ipilimumab and chemotherapy continued to show durable benefit at 4 years compared with chemotherapy alone as first-line therapy in patients with advanced non–small cell lung cancer, particularly in the PD-L1–negative and squamous populations.

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

Treatment with tovorafenib elicited encouraging and fast onset responses in heavily pretreated pediatric patients with low-grade glioma regardless of response assessment criteria, according to data from the phase 2 FIREFLY-1 trial that were presented at the 2023 ASCO Annual Meeting.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ASCO Annual Meeting. 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.

Talquetamab plus daratumumab displayed high response rates regardless of 0.4 mg/kg or 0.8 mg/kg dosing in combination with daratumumab in patients with heavily pretreated relapsed/refractory multiple myeloma, irrespective of prior treatment with CD38-directed therapy and T-cell redirection therapy.

Higher baseline HER3-positive circulating tumor cell count at baseline and reduction following treatment initiation was associated with a higher likelihood of deriving an early response with patritumab deruxtecan in patients with hormone receptor–positive or HER2-low advanced breast cancer.

The FDA has granted priority review to repotrectinib for the treatment of patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab as neoadjuvant therapy in combination with platinum-based chemotherapy for patients with resectable non–small cell lung cancer at high risk of recurrence and tumor cell PD-L1 expression of at least 1%.

Luspatercept-aamt led to a higher rate of sustained transfusion independence compared with erythropoiesis stimulating agents in patients with ESA-naïve, lower-risk myelodysplastic syndrome.

The National Comprehensive Cancer Network Guidelines now recommend the use of 18F-Fluorestradiol positron emission tomography in certain circumstances during the systemic staging workup for patients with recurrent or metastatic for estrogen receptor–positive breast cancer.

The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology have been revised to include ropeginterferon alfa-2b-njft as a preferred treatment option for patients with high- and low-risk polycythemia vera, irrespective of treatment history.

The FDA has granted an orphan drug designation to mitazalimab for use as a potential therapeutic option in patients with pancreatic cancer.

The FDA has granted an orphan drug designation to rucosopasem manganese for the treatment of patients with pancreatic cancer.

The first patients have been dosed in the phase 3b ECLIPSE PV trial, which is evaluating an accelerated dosing schedule of ropeginterferon alfa-2b-njft for the treatment of patients with polycythemia vera.

Preoperative treatment with atezolizumab, epirubicin, trastuzumab, and pertuzumab led to improved rates of pathologic complete response and decreased residual cancer burden compared with trastuzumab, pertuzumab, and chemotherapy alone in patients with early-stage HER2-positive breast cancer, according to findings from the randomized phase 2 ATHENE trial.