Phase III CARISEL study of Vocabria + Rekambys shows long-acting regimen is achievable in HIV – ViiV Healthcare

ViiV Healthcare presented positive interim data from the Phase III CARISEL study of Vocabria + Rekambys (cabotegravir + rilpivirine), which was initiated and conducted during the COVID-19 pandemic. The study evaluated perspectives of healthcare teams and people living with HIV, through surveys and interviews, around the implementation of Vocabria (cabotegravir injection) and Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys […]

Phase III IMpower010 study of Tecentriq consistent with previous studies in NSCLC and published in The Lancet – Genentech/Roche

Genentech/Roche presented new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1 at least 1%. Data from the IMpower010 trial were published simultaneously in The […]

National Institute of Health and Care Excellence (NICE) (UK) recommends Palforzia for treating peanut allergy in children – Aimmune/Nestle

NICE (UK)-Palforzia from Aimmune/Nestle is recommended, within its marketing authorisation, as an option for treating peanut allergy in children aged 4 to 17. It can be continued in people who turn 18 while on treatment. Palforzia should be used with a peanut-avoidant diet. Why the committee made these recommendations? For people with peanut allergy, strictly avoiding peanuts and being ready […]

Updated results from pivotal HER2CLIMB trial evaluating Tukysa in patients with HER2-positive breast cancer – Seagen Inc

Seagen Inc. announced the presentation of new data from exploratory analyses from the pivotal HER2CLIMB trial showing that improvement in overall survival (OS) was maintained after an additional 15.6 months of follow-up when Tukysa (tucatinib) was combined with trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer (MBC) who had stable or active brain metastases. The data were featured […]

European Commission approves Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for individuals 18 years of age and older – Merck Inc

Merck Inc., announced that the European Commission (EC) has approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The approval allows marketing of Vaxneuvance in all 27 European Union (EU) Member States plus Iceland, Norway and Lichtenstein. The use of […]

FDA grants Brukinsa accelerated approval in relapsed or refractory marginal zone lymphoma – BeiGene

BeiGene, Ltd. announced that Brukinsa (zanubrutinib) has received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.This accelerated approval is based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit […]

EMPEROR-Preserved phase III trial of Jardiance shows efficacy in heart failure – Eli Lilly + Boehringer

Jardiance (empagliflozin), from Eli Lilly and Boehringer, reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40% regardless of chronic kidney disease status at baseline, according to findings from a new prespecified sub-analysis of the EMPEROR-Preserved […]

Update on the phase IV confirmatory study of Aduhelm for Alzheimer’s disease – Biogen + Eisai

Biogen Inc. and Eisai Co., Ltd. provided an important update on the continuing progress of the Phase IV post-marketing confirmatory study of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use in Alzheimer’s disease. The companies anticipate submitting the final protocol for review to the FDA in March 2022, with the initiation of patient screening in May 2022. The study is […]

AbbVie provides update on Rinvoq for the treatment of rheumatoid arthritis in the U.S

AbbVie announced an update to the U.S. Prescribing Information and Medication Guide for Rinvoq (upadacitinib) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). This update follows a Drug Safety Communication (DSC) issued on 1 September, 2021 by the FDA following its final review of the post-marketing study, ORAL Surveillance, evaluating Xeljanz (tofacitinib) in patients with RA. […]

European Commission approves Lenvima + Keytruda to treat endometrial carcinoma – Eisai + Merck Inc.

Eisai Co., Ltd. and Merck Inc., announced that the European Commission has approved the combination of Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda, the anti-PD-1 therapy from Merck Inc., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy […]