Jordyn Sava is an assistant editor for Targeted Oncology.
SORAYA Trial Meets Primary End Point of ORR in Ovarian Cancer
Data from the SORAYA trial shows the use of mirvetuximab soravtansine monotherapy in patients with ovarian cancer to result in meaningful anti-tumor activity, consistent safety, and favorable tolerability.
FDA Approves Pembrolizumab for Select Patients With MSI-H/dMMR Advanced Endometrial Carcinoma
Pembrolizumab is now an FDA-approved treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Adjuvant Pembrolizumab Improves DFS in Stage IB-IIIA Non-Small Cell Lung Cancer
Findings show adjuvant pembrolizumab to significantly improve disease-free survival in patients with stage IB-IIIA non-small cell lung cancer following surgical resection regardless of PD-L1 expression
FDA Grants Orphan Drug Status to TCB-002 for Patients With Acute Myeloid Leukemia
Orphan drug designation has been granted to TCB-002 for use as a potential therapeutic option in patients with relapsed/refractory acute myeloid leukemia.
Raising Awareness for Polycythemia Vera is Key in Increasing Overall Survival
In an interview with Targeted Oncology, Ghaith Abu-Zeinah, discussed the factors contributing to overall survival in patients with polycythemia vera and what is expected of future research.
FDA Approves Companion Diagnostic for EGFR Therapies for Exon 19 Deletions and Exon 21 Alterations in NSCLC
The FDA has approved the FoundationOne CDx as a companion diagnostic to identify patients with non–small cell lung cancer with tumors that harbor EGFR exon 19 deletions or exon 21 substitutions.
Selinexor Improves PFS in Advanced or Recurrent Endometrial Cancer
Selinexor shows statistically significant improvement in progression-free survival in patients with endometrial cancer.
Type C Meeting With FDA Requested by Allarity to Discuss Dovitinib in Third-Line RCC
Type C meeting with the FDA requested by Allarity to discuss potential clinical paths to support approval of dovitinib as a potential option in the third-line treatment of patients with renal cell carcinoma
Relatlimab/Nivolumab Achieves Clinically Meaningful Improvement in OS for Advanced Melanoma
Relatlimab plus nivolumab demonstrated reduction in risk of progression or death and numerically improved overall survival compared to nivolumab alone.
Cabozantinib Plus Atezolizumab Shows No Overall Survival Benefit in HCC
Cabozantinib in combination with atezolizumab shows no effect on survival compared to sorafenib in patients with previously untreated advanced hepatocellular carcinoma based on results from the final analysis of the phase 3 COSMIC-312 trial.
Adjuvant and Neoadjuvant Therapies Shape Future of MIBC Treatment
Tracy Rose, MD, discussed the future of adjuvant and neoadjuvant therapy in muscle-invasive bladder cancer specifically using cisplatin-based regimens.
FDA Approves Olaparib CDx to Detect BRCA in High Risk Early Breast Cancer
The FDA approved the BRACAnalysis CDx test for use as a companion diagnostic with adjuvant olaparib to identify patients with germline BRCA-mutated for patients with HER2 negative, high-risk early-stage breast cancer.
Ribociclib Plus Letrozole Extends Survival in Patients With Metastatic Breast Cancer
Ribociclib plus letrozole demonstrated statistically significant improvement in overall survival with the combination in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer.
FDA Orphan Drug Designation Granted to HT-KIT for Mastocytosis Treatment
Orphan drug designation has been granted to HT-KIT from the FDA for the treatment of mastocytosis
Promising Results of Cabozantinib/Nivolumab in Non-Clear Cell RCC Could Guide Future Research
In an interview with Targeted Oncology, Chung-Han Lee, MD, PhD further discussed the results of the phase 2 trial of the combination of cabozantinib and nivolumab in patients with metastatic non-clear cell RCC and how it impacts the future of this space.
Pyrotinib/Capecitabine Shows Activity in HER2-Positive Breast Cancer with Brain Metastases
Pyrotinib combined with apecitabine demonstrated promising activity in patients with HER2-positive breast cancer that have brain metastases, according to findings from the prospective phase 2 PERMEATE study.
Tisagenlecleucel Not Superior to SOC as 2L Treatment for Aggressive B-cell Lymphoma
Significantly longer event-free survival was not demonstrated with tisagenlecleucel in the second-line setting when compared to standard-of-care second-line therapy in patients with refractory or early relapsed aggressive B-cell lymphoma.
FDA Grants Fast Track Designation to 7HP349 for Anti-PD-1 Metastatic Melanoma
Fast track designation has been granted to 7HP349, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor.
New Agents Advance Treatment Options for Polycythemia Vera
Srdan Verstovsek, MD, discussed the ways in which ropeginterferon and rusfertide can reduce thromboembolic events in polycythemia vera.
Batiraxcept/Cabozantinib Shows Positive Efficacy in Patients With ccRCC
Updated data from the ongoing phase 1b/2 trial of batiraxcept in combination with cabozantinib shows favorable outcomes in patients with clear cell renal cell carcinoma.
Disparities Remain in Pediatric Cancer Despite OS Improvement Over 14 Years
In an interview with Targeted Oncology, David Siegel, MD, explained the many changes seen in pediatric cancer mortality and survival over the past 40 years.
First-Line Nivolumab/Chemotherapy Could Benefit Patients With Gastric/GEJ/Esophageal Cancers
In an interview with Targeted Oncology, Ryan Sugarman, MD, discussed the CheckMate 649 trial and Q-TWiST results to provide a further understanding of survival and quality of life benefit of nivolumab plus chemo versus chemo alone.
New Treatments Emerge for Brain Metastases in HER2+ Metastatic Breast Cancer
Tailored treatment available to patients with HER2-positive metastatic breast cancer based on the presence of active central nervous system disease.
Multifaceted Approach Used for Addressing Cardiotoxicity in Breast Cancer
A team-oriented approach based on guideline-directed therapies should be used by clinicians to address patients experiencing cardiotoxicity as a result of their breast cancer, according Jean-Bernard Durand, MD.
Promising Results Shown With CAR T Cells for MCL and Indolent Lymphoma
In an interview with Targeted Oncology, Lori Leslie discussed the CAR T-cell product, brexucabtagene autoleucel, and its influence on both MCL and indolent lymphomas.
Elacestrant Improves PFS Over SOC in Advanced ER-Positive, HER2-Negative Metastatic Breast Cancer
Elacestrant demonstrates statistically significant and clinically meaningful improvement in progression-free survival for patients with ER–positive, HER2-negative mBC who previously received CDK4/6 inhibition.
Factors Influencing Transplant Eligibility in Patients With MDS
In an interview with Targeted Oncology, Ronald Paquette, MD, discussed MDS and what factors may impact the success of a patient’s treatment when undergoing transplant.
FDA Releases Guidelines for Cancer Clinical Trials, Aligning With Goals of the Biden Administration
The FDA issued 3 final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden's 2016 Cancer Moonshot initiative.
DKN-01 Triplet Shows Encouraging Early Efficacy/Safety in Frontline Gastroesophageal Adenocarcinoma
Findings show DKN-01, tislelizumab, and capecitabine/oxaliplatin (CAPOX) combination to be well tolerated and have encouraging clinical activity as frontline treatment of patients with advanced gastroesophageal adenocarcinoma.
A Look Back at the FDA News from February 2022
Here's a look back at all the FDA happenings from February 2022.
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