Phase III trial

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 […]

Otsuka and Lundbeck’s Rexulti (brexpiprazole) has become the first pharmacological treatment to be approved in the US for agitation associated with dementia due to Alzheimer’s disease. The Food and Drug Administration (FDA) has approved the companies’ supplemental New Drug Application (sNDA). Agitation is a common neuropsychiatric symptom in Alzheimer’s dementia and one of the most […]

The European Commission (EC) has granted marketing authorisation for Akeega (niraparib and abiraterone acetate [AA]) for adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic). The drug is given in the form of a dual action tablet (DAT), with prednisone or prednisolone, and is approved in patients for whom chemotherapy is […]

A Phase III clinical trial led by physicians in the US has shown that adding investigational drug motixafortide significantly increases the number of stem cells that can be harvested compared with treatment with the standard agent alone. The standard treatment for patients with multiple myeloma often includes stem cell transplantation in which the patient’s own […]

The addition of pembrolizumab (Keytruda) to gemcitabine and cisplatin improved overall survival in patients with untreated metastatic or unresectable biliary tract cancer, according to results from the Phase III KEYNOTE-966 clinical trial. The results were presented at the AACR Annual Meeting 2023, held April 14-19 and published in The Lancet. Biliary tract cancers are rare […]

Patients with treatment-naïve resectable non-small cell lung cancer (NSCLC) who received neoadjuvant durvalumab (Imfinzi) plus chemotherapy and adjuvant durvalumab monotherapy had improved event-free survival (EFS) and pathological complete response (pCR) compared with those who received neoadjuvant chemotherapy alone. The results from the Phase III placebo-controlled AEGEAN clinical trial were presented at the AACR Annual Meeting […]

Adjuvant therapy with atezolizumab (Tecentriq) and bevacizumab (Avastin) increased recurrence-free survival of patients with hepatocellular carcinoma (HCC) following surgical resection or ablation, according to the results from a Phase III trial. The results of the IMbrave050 clinical trial were presented at the AACR Annual Meeting 2023, held April 14-19. The mainstays of curative therapies for […]

CSL’s Hemgenix (etranacogene dezaparvovec) has been authorised as the first gene therapy for adults with severe and moderately severe haemophilia B (congenital Factor IX (FIX) deficiency) in Great Britain. It has been granted a marketing authorisation for patients without a history of FIX inhibitors by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The […]

Pfizer and Astellas have announced positive top-line results from the Phase III EMBARK trial evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). Patients enrolled in the trial were randomised to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. The study met […]

The combination therapy of niraparib and abiraterone acetate (AA) could become the first dual action tablet (DAT) available in the European Union for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations.  Janssen’s Akeega has been recommended for marketing authorisation when given with prednisone (P) or prednisolone by the Committee for Medicinal Products for Human Use […]

Under a new agreement, Destiny Pharma and Sebela Pharmaceuticals will co-develop NTCD-M3, Destiny’s lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence.  It is anticipated that Sebela will lead and finance the future clinical development and commercialisation activities of NTCD-M3 in North America.   Destiny will keep most rights for Europe and Rest of […]

Covid-19 booster candidate UB-612 has achieved its immunogenicity endpoints in a head-to-head trial against three vaccine platforms: mRNA (Pfizer-BioNTech’s BNT162b2), adenovirus vector (AstraZeneca’s ChAdOx1-S), and inactivated virus (Sinopharm’s BIBP).  The results show UB-612 elicits superior neutralising antibody titers and seroconversion rates against both Wuhan and Omicron BA.5 variants compared to adenovirus vector (ChAdOx1-S) and inactivated […]