News &amp; Updates

The poly(ADP-ribose) polymerase (PARP) inhibitor fluzoparib appears to work in the treatment of patients with germline BRCA1/2-mutated, platinum-sensitive relapsed ovarian cancer, with an acceptable safety profile, as shown in a phase II trial.

Fluzoparib shows promising activity against BRCA-mutant relapsed ovarian cancer

Original New Drug Application Approvals by US FDA (01 - 15 May 2021)

New drug applications approved by US FDA as of 01-15 May 2021 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.

Original New Drug Application Approvals by US FDA (01 - 15 May 2021)

$Meta-analysis: Lenvatinib boosts survival in refractory thyroid carcinoma with caveat$

Meta-analysis: Lenvatinib boosts survival in refractory thyroid carcinoma with caveat

17 May 2021 by

In the treatment of patients with radioiodine-refractory thyroid carcinoma, lenvatinib may improve their chances of survival but at the cost of a high adverse event rate, according to the results of a meta-analysis.

Meta-analysis: Lenvatinib boosts survival in refractory thyroid carcinoma with caveat

Tislelizumab trumps docetaxel in pre-treated NSCLC

17 May 2021 by

The anti-PD-1 antibody tislelizumab may help improve patient outcomes vs docetaxel as second- or third-line treatment for advanced or metastatic non–small-cell lung cancer (NSCLC) regardless of histology or PD-L1 expression, interim findings from the phase III RATIONALE 303 study have shown.

Tislelizumab trumps docetaxel in pre-treated NSCLC

Lumasiran shows therapeutic potential for primary hyperoxaluria type 1

17 May 2021 by

The RNAi* therapeutic agent lumasiran demonstrated favourable clinical outcomes for primary hyperoxaluria type 1 (PH1) in both paediatric and adult patients, according to the results of the phase III ILLUMINATE-A and ILLUMINATE-B trials presented at PAS 2021.

Lumasiran shows therapeutic potential for primary hyperoxaluria type 1

Osteoporosis medication yields survival benefits in epilepsy

Adult patients with epilepsy who are initiated on osteoporosis treatment appear to have a reduced 3-year risk of mortality, with bisphosphonates showing a unique protective effect compared with other drugs, according to a study.

Osteoporosis medication yields survival benefits in epilepsy

Secukinumab shows sustained improvement in paediatric psoriasis

16 May 2021 by

Treatment with either low-dose (LD) or high-dose (HD) secukinumab showed continued improvement in PASI* and IGA** responses up to 24 weeks in children and adolescents with moderate-to-severe plaque psoriasis, according to updated results of a trial presented at PAS 2021.

Secukinumab shows sustained improvement in paediatric psoriasis

16 May 2021

IBD remission may be maintained even after anti-TNF discontinuation

A large number of patients with inflammatory bowel disease (IBD) remain on remission following discontinuation of antitumour necrosis factor alpha (anti‐TNF) treatment, a study has found. Furthermore, retreatment with the same anti-TNF is usually effective for managing relapse.

IBD remission may be maintained even after anti-TNF discontinuation

First-line tebentafusp may extend OS in HLA-A*02:01-positive metastatic uveal melanoma

15 May 2021 by

First-line treatment with the bispecific fusion protein tebentafusp demonstrated an overall survival (OS) benefit in patients with human leukocyte antigen (HLA)-A*02:01-positive metastatic uveal melanoma (mUM), according to a phase III, open-label trial presented at AACR 2021.

First-line tebentafusp may extend OS in HLA-A*02:01-positive metastatic uveal melanoma

Beta-1 selective blockers linked to breast cancer risk

Women using beta-1 selective blockers may be at increased risk of developing breast cancer, with the association showing a dose-response pattern, according to a study.

Beta-1 selective blockers linked to breast cancer risk