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Original New Drug Application Approvals by US FDA (16 - 31 October 2022)

20221102095557

New drug applications approved by US FDA as of 16 - 31 October 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Teclistamab demonstrates clinical activity for R/R MM

Audrey Abella, 20220811100000

The T-cell-redirecting bispecific antibody teclistamab induced deep and durable responses in patients with triple-class-exposed relapsed or refractory multiple myeloma (R/R MM), findings from the phase I/II MajesTEC-1 trial have shown.

Original New Drug Application Approvals by US FDA (16 - 31 July 2022)

20220731000000

New drug applications approved by US FDA as of 16 - 31 July 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Upfront ASCT + RVd improves PFS in NDMM

Roshini Claire Anthony, 20220716110001

Upfront autologous stem cell transplantation (ASCT) plus lenalidomide, bortezomib, and dexamethasone (RVd) significantly improves progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), results of the phase III DETERMINATION trial showed.

Post-transplant KRd a new SoC for MM?

Audrey Abella, 20220707100000

In the ongoing phase III ATLAS study evaluating patients with newly diagnosed multiple myeloma (MM), progression-free survival (PFS) was better with maintenance treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) than lenalidomide (R) alone after autologous stem-cell transplantation (ASCT).

$Ixa-dex, pom-dex both effective in heavily pretreated relapsed, refractory multiple myeloma$

Ixa-dex, pom-dex both effective in heavily pretreated relapsed, refractory multiple myeloma

20220608180000

Ixazomib-dexamethasone (ixa-dex) and pomalidomide-dexamethasone (pom-dex) achieve comparable levels of efficacy and safety in relapsed and refractory multiple myeloma (RRMM) patients who had already been exposed to prior lenalidomide-based regimens, a recent study has found.

Original New Drug Application Approvals by US FDA (16 - 31 May 2022

20220531000000

New drug applications approved by US FDA as of 16-31 May 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Accelerated daratumumab infusion safe, well tolerated in multiple myeloma

20220529120000

Accelerated administration of daratumumab, an anti-CD3 monoclonal antibody approved for multiple myeloma, is safe and well tolerated when given following at least two standard infusions, suggest the results of a recent study.

High BMI might promote MGUS progression to multiple myeloma

20220517180000

In individuals with monoclonal gammopathy of undetermined significance (MGUS), obesity or high body mass index (BMI) seems to aggravate the risk of disease progression to multiple myeloma (MM), an effect that appears to be stronger in women, a recent study has found.

Add-on ixazomib does not improve cyclophosphamide-dexamethasone combo in frail MM patients

20220517060000

The addition of ixazomib to cyclophosphamide-dexamethasone treatment does not seem to result in better survival and response rates in patients with newly diagnosed and relapsed multiple myeloma (MM), a recent study has found.

Improving survival outcomes with systemic therapy in advanced hepatocellular carcinoma

02 Apr 2021

At the 3rd Bayer Hepatocellular Carcinoma (HCC) Masterclass, three distinguished speakers shared their insights into the management of intermediate and advanced HCC in Malaysia. Topics discussed include current treatment landscape and updates in disease management, as well as two case studies that highlighted the role of tyrosine kinase inhibitors (TKIs) in improving the overall survival (OS) of patients with advanced HCC.

Management of MDROs in the ICU and the role of newer antimicrobial agents

Prof. David Paterson, 30 Mar 2021

Intensive care unit (ICU) patients are at risk of developing serious infections with multidrug-resistant organisms (MDROs), which require appropriate and adequate antibiotic coverage. Early empirical coverage is pivotal in saving patients’ lives. At a recent webinar co-organized by the Society of Infectious Disease (Singapore) and Pfizer, renowned Professor David Paterson, Professor of Medicine and Director, The University of Queensland Centre for Clinical Research, and Consultant Infectious Diseases Physician, Royal Brisbane and Women’s Hospital, Brisbane, Australia, discussed the role of newer antimicrobial agents, including ceftazidime-avibactam (Zavicefta) in the management of MDROs in the ICU. Dr Wong Sin Yew, Infectious Disease Physician at Gleneagles Medical Centre and Mount Elizabeth Novena Specialist Centre, Singapore, chaired the event.

Relationship between tumour response to systemic therapy and overall survival in unresectable hepatocellular carcinoma

Dr Raghav Sundar, 09 Sep 2019

Overall survival (OS) is currently the primary criteria in assessing the efficacy of a cancer treatment. Dr Raghav Sundar, a consultant medical oncologist at the National University Hospital, Singapore, details the crucial role played by tumour response in evaluating treatment efficacy, with a focus on the multiple kinase inhibitor lenvatinib in the treatment of hepatocellular carcinoma (HCC).