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Johnson& Johnson

Johnson & Johnson Reports the US FDA’s sNDA Acceptance & Priority Review of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:The US FDA has accepted sNDA & granted priority review to Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA-mutated mHSPCsNDA was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…

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Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

Shots:FDA has approved Tremfya (SC; Wk. 0, 4 & then Q8W) for children (≥6yrs.; ≥40kg) with mod. to sev. plaque PsO, who are candidates for systemic therapy or phototherapy, or active PsA; an FDA application was also filed to add joint damage inhibition in active PsA adults to Tremfya’s labelPlaque PsO approval was based…

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Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the EU

Shots:J&J has launched Shockwave Javelin peripheral IVL catheter in the EU to modify calcium & cross extremely narrowed vessels in pts with peripheral artery disease (PAD)Shockwave Javelin was studied in FORWARD PAD IDE trial that demonstrated similar safety & effectiveness compared to balloon-based Shockwave IVL catheters, regardless of the nature of calcified lesions…

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The US FDA Approves Johnson & Johnson’s Inlexzo for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots:The US FDA has approved Inlexzo for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumorsApproval was based on the P-IIb (SunRISe-1) trial, assessing Inlexzo in pts ineligible or opting out of radical cystectomy, which showed an 82% CR rate, with 51% remaining cancer-free for at least 1yr. post-responseInlexzo is…

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Johnson& Johnson

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

Shots:The EC has approved a label extension for Imbruvica (ibrutinib) + R-CHOP alternating with R-DHAP (without ibrutinib), followed by ibrutinib monotx., for the treatment of previously untreated MCL pts ineligible for ASCTApproval was based on ongoing P-III (TRIANGLE) trial in 870 EU pts, assessing ibrutinib + chemoimmunotherapy (CIT) ± ASCT & 2yr. ibrutinib…

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