Chris Ryan

Articles

Neoadjuvant Nivolumab/Ipilimumab Combo Elicits Responses, Safety in Resectable HCC

September 13th 2023

Neoadjuvant treatment with the combination of nivolumab and ipilimumab led to responses and was well tolerated in patients with resectable hepatocellular carcinoma.

European Approval Sought for Erdafitinib in Locally Advanced or Metastatic FGFR3+ Urothelial Carcinoma

September 12th 2023

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of erdafitinib for the treatment of adult patients with locally advanced, unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who experienced disease progression during or following at least 1 line of therapy containing a PD-1/PD-L1 inhibitor.

FDA Approval Sought for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma

September 11th 2023

A rolling new drug application seeking the approval of tovorafenib monotherapy for the treatment of patients with relapsed or progressive pediatric low-grade glioma has been submitted to the FDA.

FDA Approves Motixafortide Plus Filgrastim for ASCT in Multiple Myeloma

September 11th 2023

The FDA has approved motixafortide (Aphexda) in combination with filgrastim (Neupogen) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplant in patients with multiple myeloma.

Tisotumab Vedotin Improves OS in Recurrent/Metastatic Cervical Cancer

September 5th 2023

Treatment with tisotumab vedotin-tftv monotherapy led to an improvement in overall survival compared with chemotherapy alone in patients with recurrent or metastatic cervical cancer that progressed on or after frontline therapy.

Alectinib Meets DFS End Point in ALK+ Early-Stage NSCLC

September 1st 2023

Adjuvant treatment with alectinib generated a statistically significant and clinically meaningful improvement in disease-free survival compared with platinum-based chemotherapy in patients with completely resected stage IB to IIIA, ALK-positive non–small cell lung cancer.

Tagraxofusp Receives Orphan Drug Designation in Japan for BPCDN

August 31st 2023

The Japanese Ministry of Health, Labor and Welfare has granted an orphan drug designation to tagraxofusp-erzs for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm.

Mezigdomide Plus Dexamethasone Elicits Responses With Acceptable Safety in R/R Myeloma

August 30th 2023

Treatment with combination of mezigdomide and dexamethasone produced responses with a safety profile that consisted primarily of myelotoxic adverse effects in heavily pretreated patients with relapsed/refractory multiple myeloma.

Novartis Discontinues Development of NIS793 in Pancreatic Cancer

August 30th 2023

Novartis will discontinue the development of the anti-TGFß monoclonal antibody NIS793 for the treatment of patients with pancreatic cancer and other malignancies, according to a SEC filing from Xoma.

FDA Grants Orphan Drug Designation to Bexmarilimab for AML

August 29th 2023

The FDA has granted an orphan drug designation to bexmarilimab for the treatment of patients with acute myeloid leukemia.

FDA Approval Sought for Erdafitinib in Locally Advanced or Metastatic FGFR3+ Urothelial Carcinoma

August 29th 2023

A supplemental new drug application seeking the full approval of erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA.

Talquetamab Wins Approval in Europe for Relapsed/Refractory Myeloma

August 22nd 2023

The European Commission has granted conditional marketing authorization to talquetamab-tgvs monotherapy for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 3 prior therapies and have demonstrated disease progression on the last therapy.

FDA Accepts NDA for Imetelstat in Lower-Risk MDS

August 21st 2023

The FDA has accepted a new drug application seeking the approval of imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndrome.

FDA Grants Orphan Drug Designation to MAb-AR20.5 in Pancreatic Cancer

August 21st 2023

The FDA has granted an orphan drug designation to the IgG1k type murine monoclonal antibody MAb-AR20.5 for the treatment of patients with pancreatic cancer.

Second-Line Axi-Cel Elicits Complete Metabolic Responses in Transplant-Ineligible LBCL

August 18th 2023

Second-line treatment with axicabtagene ciloleucel led to an investigator-assessed, 3-month complete metabolic response rate of 71.0% in patients with large B-cell lymphoma who were ineligible for autologous stem cell transplant.

European Commission Approves Reduced Dosing of Teclistamab in Relapsed/Refractory Myeloma

August 18th 2023

The European Commission has approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved a complete response or better for a minimum of 6 months.

EMA Accepts Marketing Application for Odronextamab in R/R DLBCL or Follicular Lymphoma

August 17th 2023

The European Medicines Agency has accepted a marketing authorization application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.

FDA Grants Breakthrough Device Designation to HLA-LOH Companion Diagnostic Test

August 16th 2023

The FDA has granted a breakthrough device designation to HLA-LOH as a companion diagnostic test, according to an announcement from Tempus.

Repotrectinib Sustains ORR, Safety in Locally Advanced or Metastatic ROS1+ NSCLC

August 16th 2023

Treatment with repotrectinib continued to produce high and durable responses with a manageable safety profile in patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer who were naïve to a TKI or previously treated with 1 TKI and no chemotherapy.

Tucatinib Plus T-DM1 Improves PFS in Previously Treated HER2+ Metastatic Breast Cancer

August 16th 2023

The combination of tucatinib and ado-trastuzumab emtansine elicited an improvement in progression-free survival compared with placebo plus T-DM1 in patients with HER2-positive metastatic breast cancer who received previous treatment with a taxane and trastuzumab in any setting.