Phase III trial

In the Phase III innovaTV 301 trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, Tivdak (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival (OS). An independent data monitoring committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The key […]

The US Food and Drug Administration (FDA) has expanded the use of Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) to include first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The approval is for the treatment of anaemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk MDS who may […]

AstraZeneca’s Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF. The drug was previously approved in China but was limited to HF patients with reduced ejection fraction (HFrEF). The approval by China’s National Medical Products […]

Ipsen’s Sohonos (palovarotene) has become the first drug approved for patients with fibrodysplasia ossificans progressiva (FOP) in the US, following the granting of a marketing authorisation by the Food and Drug Administration (FDA). The capsules are approved for reduction in the volume of new heterotopic ossification (extra-skeletal bone formation) in adults and children aged eight […]

Janssen’s Akeega (niraparib and abiraterone acetate) is now available in the US for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) following FDA approval. It is the first dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, to be approved in this indication. “As a physician, […]

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Eli Lilly’s mirikizumab for moderately to severely active ulcerative colitis. The drug is approved in adult patients who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. “Ulcerative colitis is […]

Takeda has revealed favourable interim results from its Phase III crossover trial evaluating the safety and efficacy of TAK-755 (recombinant ADAMTS13) replacement therapy for the prophylactic treatment of congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare, chronic and debilitating blood clotting disorder caused by a deficiency in ADAMTS13 enzyme. Clinical presentation of cTTP lies […]

Janssen has submitted a marketing authorisation application to the European Medicines Agency (EMA) seeking approval of single tablet combination therapy (STCT) of macitentan and tadalafil for pulmonary arterial hypertension (PAH). The single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) is intended for the long-term treatment of pulmonary arterial hypertension (PAH, World […]

The US Food and Drug Administration (FDA) has given approval to Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection with Enhanze for subcutaneous (SC) use for the treatment of generalised myasthenia gravis (gMG). The treatment is approved in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Vyvgart Hytrulo is a subcutaneous product combination of efgartigimod […]

The US Food and Drug Administration (FDA) has approved Minoryx Therapeutics’ Phase III clinical trial (CALYX) of leriglitazone, to treat adult male X-linked Adrenoleukodystrophy (X-ALD) patients with cerebral Adrenoleukodystrophy (cALD). Patient recruitment is expected to start by the end of Q2 2023 with results anticipated by late 2025. Marc Martinell, CEO of Minoryx, said: “CALYX […]

Bellerophon Therapeutics has announced it will close its Phase III study of INOpulse, its treatment for fibrotic Interstitial Lung Disease (fILD), after the trail failed to meet its primary endpoint. The REBUILD clinical trial was designed as a randomised, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of INOpulse for the treatment of […]

Positive primary endpoint data from Novartis’ pivotal Phase III NATALEE trial has been presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Data showed that Kisqali (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human […]

The US Food and Drug Administration (FDA) has approved Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo in individuals 60 years and older. Abrysvo is unadjuvanted and composed of two preF proteins selected to optimise protection against RSV A and B strains and was observed to be safe and effective. “A vaccine […]

Positive results from the ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo. The trial assessed osimertinib as an adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete […]

Lynparza (olaparib) has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). The PARP inhibitor, developed by AstraZeneca and Merck (MSD), is approved in combination with abiraterone and prednisone or prednisolone. This approval was based on a subgroup analysis of the […]

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed and lenalidomide-refractory multiple myeloma. The application is supported by data from the Phase III CARTITUDE-4 study, which evaluated the safety profile and efficacy of cilta-cel […]