Johnson & Johnson : ERLEADA® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates marketscreener.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from marketscreener.com Daily Mail and Mail on Sunday newspapers.
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LONDON, April 22, 2021 /PRNewswire/ GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company s Biologics License Application. JEMPERLI is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
(1)
EUSA Pharma (UK) Limited (
EUSA Pharma ), a global biopharmaceutical company focused on oncology and rare diseases, announced that the National Comprehensive Cancer Network
(NCCN
) for B-Cell Lymphomas to include siltuximab (SYLVANT
) as the preferred primary treatment for patients with human immunodeficiency virus-negative [HIV(-)] and human herpesvirus 8-negative [HHV-8(-)] multicentric Castleman disease (MCD), also known as idiopathic multicentric Castleman disease (iMCD), regardless of histopathologic subtype.
1 Siltuximab is currently approved in more than 40 countries worldwide for the treatment of all histopathologic subtypes of iMCD, a rare, life-threatening and debilitating orphan condition of the lymph nodes and related tissues. 2,3 The update is based on a 2020 publication which demonstrated that there is insufficient evidence to guide treatment based solely on lymph node histopathologic subtype.
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RARITAN, N.J., Feb. 8, 2021 /PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the final analysis of the Phase 3 TITAN study, which demonstrated the continued statistically significant benefit of the addition of ERLEADA
® (apalutamide) to androgen deprivation therapy (ADT) in overall survival (OS) in patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of extent of disease, when compared to placebo plus ADT.
1 Results will be featured in an oral presentation at the American Society of Clinical Oncology s Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #11; Rapid Abstract Session: Prostate Cancer, February 11, 3:30 PM-4:15 PM EST).
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RARITAN, N.J., Feb. 8, 2021 /PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the randomized, double-blind, placebo-controlled Phase 3 ACIS study, which met the primary endpoint of radiographic progression-free survival (rPFS) with a 31 percent reduction in the risk of radiographic progression or death in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Patients in the trial received either a combination of ERLEADA
® and ZYTIGA
® plus prednisone (control arm).
1 Results will be featured in an oral presentation at the American Society of Clinical Oncology s Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #9; Oral Abstract Session: Prostate Cancer, February 11, 12:45 PM-2:00 PM EST).