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FDA Launches Priority Review of Enfortumab Vedotin Plus Pembrolizumab in Advanced Urothelial Cancer
The FDA has granted enfortumab vedotin plus pembrolizumab priority review status for patients with locally advanced or metastatic urothelial cancer following data from the phase 3 EV-302/KEYNOTE-A39 trial.
FDA Revisits Pembrolizumab’s Gastric Cancer Indication
The FDA has restricted the indication for gastric cancer to only include patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test.
Phase 3 Trial Supports Amivantamab Plus Lazertinib Over Osimertinib in Advanced EGFR+ NSCLC
The median progression-free survival was 23.7 months with the combination vs 16.6 months with osimertinib alone.
Tisotumab Vedotin Reduces Risk of Death by 30% in Recurrent/Metastatic Cervical Cancer
The 12-month overall survival rates were 48.7% and 35.3% with tisotumab vedotin and chemotherapy, respectively, among patients with recurrent or metastatic cervical cancer.
Amivantamab Significantly Improves Progression-Free Survival in EGFR exon 20 insertion–positive NSCLC
Amivantamab plus chemotherapy nearly doubled the progression-free survival in patients with EGFR Exon 20-mutated non–small-cell lung cancer.
Atezolizumab Plus Cabozantinib Meets PFS End Point in Phase 3 CONTACT-02 Trial in Hormone Therapy–Pretreated mCRPC
Cabozantinib and atezolizumab led to a statistically significant progression-free survival improvement in patients with metastatic castration-resistant prostate cancer and measurable soft tissue disease.
FDA Delivers Complete Response Letter to Remestemcel-L in Pediatric Steroid-Refractory aGVHD
The resubmitted biologics license application for remestemcel-L has been issued a complete response letter.
Allogeneic CAR T-Cell Therapy CB-010 Demonstrates Potential in Phase 1 Relapsed/Refractory Non-Hodgkin Lymphoma Trial
CB-010 led to a 94% overall response rate among 16 patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
Capivasertib Plus Fulvestrant Under Priority Review for Advanced HR+ Breast Cancer
The FDA has launched a priority review of capivasertib and fulvestrant based on data from the phase 3 CAPItello-291 trial.
Spleen Volume Reduction Associated With Overall Survival Benefit in Patients With Myelofibrosis Receiving Pacritinib
For patients with myelofibrosis receiving pacritinib, spleen volume reduction was associated with improved overall survival.
Repotrectinib Under Priority Review for ROS1+ NSCLC
The FDA has launched a priority review of repotrectinib based on data from the phase 1/2 TRIDENT-trial.
Liso-cel Demonstrates Rapid, Durable Responses in Patients with Relapsed/Refractory CLL/SLL
The phase 1/2 TRANSCEND CLL 004 trial met its primary end point by demonstrating that lisocabtagene maraleucel elicited responses in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.
Chemotherapy Plus Nivolumab/Ipilimumab Demonstrates OS Advantage Over Chemotherapy Alone in Metastatic NSCLC
Frontline chemoimmunotherapy was associated with improved median overall survival, compared with chemotherapy alone, in patients with advanced non–small cell lung cancer.
Cancer Vaccine mRNA-4157 Improves Recurrence-Free Survival for Patients With High-Risk Melanoma
Adjuvant mRNA-4157, in combination with pembrolizumab, improved recurrence-free survival, and distant metastasis-free survival, for patients with high-risk melanoma.
Sintilimab Minimizes Disease Recurrence Rates in Locally Advanced Nasopharyngeal Carcinoma
Sintilimab plus chemoradiotherapy was associated with better event-free survival rates in locally advanced nasopharyngeal carcinoma than chemoradiotherapy alone.
Ropeginterferon Alfa-2b Listed in NCCN Guidelines as A Preferred Polycythemia Vera Treatment
Updated National Comprehensive Cancer Network guidelines recommend ropeginterferon alfa-2b for patients with polycythemia vera.
Luspatercept Elicits High Transfusion Independence Rates in Lower-Risk MDS
Over half of patients with lower-risk myelodysplastic syndrome treated with luspatercept achieved transfusion independence.
Preoperative Treatment with Atezolizumab/Epirubicin Plus Trastuzumab/Pertuzumab Elicits High pCR Rate in Patients With Early HER2+ Positive Breast Cancer
Patients with early-stage HER2-positive breast cancer experienced a high rate of pathologic complete response with combined preoperative treatment with atezolizumab, epirubicin, trastuzumab, and pertuzumab.
Trastuzumab Deruxtecan Exhibits Favorable Safety Profile in DESTINY-Breast04 Follow-Up
Trastuzumab deruxtecan outperformed investigators choice of therapy, in terms of safety, among patients with HER2-Low Metastatic Breast Cancer.
Cilta-Cel Delivers High Response Rates in Early Relapsed/Refractory Myeloma, According to Data Leak
Data that was leaked from a 2023 EHA Hybrid Congress Abstracts demonstrated that ciltacabtagene autoleucel reduced the risk of disease progression in patients with relapsed/refractory multiple myeloma.
Perioperative Durvalumab Plus Neoadjuvant Chemotherapy Outperforms Placebo in Resectable NSCLC
The pathologic complete response rate with durvalumab was 17.2% vs 4.3% with placebo, reflecting an absolute difference of 12.9%.
Trastuzumab Biosimilar BLA Accepted for HER2+ Breast Cancer and Gastric Cancer
The FDA has accepted a biologics license application for a proposed trastuzumab biosimilar. The therapy is being considered as adjuvant therapy for certain HER2-overexpressing cancers.
Neoadjuvant Olaparib Leads to High Optimal Resection Rate in BRCA-Mutated Ovarian Cancer
With a follow-up of 11.7 months, the estimated 12-month progression-free survival rate was 81% in patients who received neoadjuvant olaparib for BRCA-positive ovarian cancer.
Neoadjuvant Nivolumab Continues to Deliver EFS Benefit to Patients with Resectable NSCLC
At a median of 44.1 months follow-up, the median event free survival was not reached with nivolumab plus chemotherapy vs 21.1 months with chemotherapy alone.
Frontline Cemiplimab Plus Chemotherapy Offers Continued Survival Advantage to Patients With Advanced NSCLC
Adding cemiplimab to platinum-doublet chemotherapy improved overall and progression-free survival in patients with advanced non-small cell lung cancer.
ODAC Votes in Favor Of Polatuzumab Vedotin in Patients With Treatment Naïve LBCL
The FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 in support of the benefit-risk profile displayed by polatuzumab vedotin-piiq in patients with previously untreated large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified.
Pembrolizumab Misses Mark in mCRPC, EGFR-Mutant NSCLC Trials
In both the KEYNOTE-641 and KEYNOTE-789 trials, pembrolizumab, in addition to standard therapies, did not improve survival outcomes in their target populations.
Atezolizumab Does Not Demonstrate Significant OS Benefit Over Chemotherapy in Untreated Locally Advanced or Metastatic Urothelial Cancer
Atezolizumab did not yield a significant improvement in overall survival compared with placebo plus platinum-based chemotherapy and gemcitabine in patients with untreated locally advanced or metastatic urothelial cancer.
ODAC Votes To Continue Dostarlimab Research in dMMR/MSI-H Locally Advanced Rectal Cancer
In an 8 to 5 vote, ODAC voted in support of launching 2 single-arm trials seeking to characterize the risk-benefit profile of dostarlimab for patients with dMMR/MSI-H locally advanced rectal cancer.
Mitazalimab Plus mFOLFIRINOX Boosts Responses in Previously Untreated Metastatic Pancreatic Cancer
A combined regimen of mitazalimab and mFOLFIRINOX resulted in a 52% objective response rate among 23 patients with metastatic pancreatic cancer.
Olanzapine Significantly Reduces CINV in Patients Receiving MEC
Reimagining Frailty Screenings in Head and Neck Cancer
Screening for Pain and Depression is Not Enough in Cancer Care
Niraparib-Based Triplet Therapy Offers OS Advantage in BRCA1/2+ mCRPC
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