Frontline Domvanalimab Plus Zimberelimab Improves Responses in PD-L1–High Metastatic NSCLC
December 22nd 2022The combination of domvanalimab plus zimberelimab with or without etrumadenant generated an improvement in overall response rate and progression-free survival compared with zimberelimab alone in patients with PD-L1–high metastatic non–small cell lung cancer, according to findings from the phase 2 ARC-7 trial.
Read More
European Commission Approves Olaparib Plus Abiraterone and Prednisone/Prednisolone for mCRPC
December 21st 2022The European Commission has approved the combination of olaparib plus abiraterone acetate and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.
Read More
FDA Expands Approval of Pemetrexed Injection for Metastatic NSCLC Without EGFR/ALK Aberrations
December 20th 2022The FDA has approved an additional indication for pemetrexed by injection, an alternative to standard pemetrexed, in combination with pembrolizumab and platinum-based chemotherapy for the initial treatment of patients with metastatic, nonsquamous non–small cell lung cancer without EGFR or ALK genomic tumor aberrations.
Read More
FDA Approval Sought for Talquetamab in Relapsed/Refractory Multiple Myeloma
December 9th 2022A biologics license application (BLA) has been submitted to the FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma, according to an announcement from Janssen.
Read More
RP1 Plus Nivolumab Elicits Responses in Melanoma After Progression on Anti–PD-1 Therapy
December 7th 2022The combination of vusolimogene oderparepvec and nivolumab generated promising responses in patients with cutaneous melanoma who failed previous anti–PD-1 therapy, according to initial data from the phase 2 IGNYTE trial.
Read More
Sintilimab Plus Anlotinib Improves Responses, PFS Vs Chemotherapy in Untreated NSCLC
December 5th 2022The combination of sintilimab and anlotinib elicited improved responses and progression-free survival compared with chemotherapy in previously untreated patients with metastatic non–small cell lung cancer.
Read More
FDA Issues Complete Response Letter for Omburtamab BLA for Pediatric Metastatic Neuroblastoma
December 2nd 2022The FDA has issued a complete response letter to the biologics license application seeking the approval of 131I-omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.
Read More
Dostarlimab Plus Chemotherapy Combo Meets PFS End Point in Advanced or Recurrent Endometrial Cancer
December 2nd 2022Dostarlimab plus standard-of-care chemotherapy, followed by dostarlimab alone, produced a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with primary advanced or recurrent endometrial cancer.
Read More
FDA Grants Fast Track Designation to Batiraxcept for Advanced or Metastatic Clear Cell RCC
November 30th 2022The FDA has granted a fast track designation to batiraxcept for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma who have progressed after 1 or 2 prior lines of systemic therapy that include both immuno-oncology–based and VEGF TKI–based therapies, either in combination or sequentially.
Read More
Nivolumab/Ipilimumab Combo Elicits 100% ORR in Checkpoint Inhibitor–Naïve Merkel Cell Carcinoma
November 29th 2022The combination of nivolumab and ipilimumab, irrespective of the addition of stereotactic body radiation therapy, generated an overall response rate of 100% in patients with Merkel cell carcinoma who were naïve to immune checkpoint inhibitors.
Read More
MHRA Approves Darolutamide Plus ADT and Docetaxel for Metastatic HSPC
November 29th 2022The United Kingdom’s Medicines and Healthcare products Regulatory Agency has approved darolutamide tablets in combination with androgen deprivation therapy and docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.
Read More
Japan Approves Trastuzumab Deruxtecan for Previously Treated HER2+ Metastatic Breast Cancer
November 28th 2022Japan’s Ministry of Health, Labor, and Welfare has approved trastuzumab deruxtecan for the treatment of adult patients with HER2-positive unresectable or recurrent breast cancer after prior chemotherapy, which includes trastuzumab and a taxane.
Read More
FDA Extends PDUFA Date for BLA of Omidubicel in Blood Cancers Requiring Transplant
November 23rd 2022The FDA has extended the Prescription Drug User Fee Act goal date to May 1, 2023, for the biologics license application seeking the approval of omidubicel for patients with blood cancers in need of allogenic hematopoietic stem cell transplant.
Read More
Belantamab Mafodotin to Be Withdrawn From US Market for Relapsed/Refractory Myeloma
November 22nd 2022GlaxoSmithKline plc has initiated the process to withdraw the United States marketing authorization for belantamab mafodotin-blmf for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior therapies.
Read More
European Commission Approves Cemiplimab for Recurrent or Metastatic Cervical Cancer
November 22nd 2022The European Commission has approved cemiplimab-rwlc monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer who have progressed on or after platinum-based chemotherapy.
Read More
The combination of pembrolizumab and physician’s choice of chemotherapy produced a statistically significant overall survival benefit vs chemotherapy plus placebo in patients with HER2-negative, locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Read More
Zandelisib Elicits High Response Rates in Indolent Non-Hodgkin Lymphoma
November 21st 2022The oral PI3Kδ inhibitor zandelisib produced an overall response rate in Japanese patients with relapsed/refractory indolent B-cell non-Hodgkin lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and Waldenström macroglobulinemia.
Read More
FDA Grants Priority Review to Epcoritamab for Relapsed/Refractory LBCL
November 21st 2022The FDA has accepted and granted priority review to a biologics license application seeking the apporoval of epcoritamab in patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.
Read More
Iovance to Address FDA Requests for BLA of Lifileucel in Advanced Melanoma
November 21st 2022After receiving FDA feedback regarding supplemental assay validation information and comparability data for lifileucel in advanced melanoma, Iovance Biotherapeutics will address these comments and plans to complete its rolling biologics license application submission during the first quarter of 2023.
Read More