Category: Oncology

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

FDA Approves Monthly Dosing for J&J’s Rybrevant Faspro, Marking a New Era in Lung Cancer Treatment

JohnsonAndJohnson

FDA approves a new simplified monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in combination with LAZCLUZE (lazertinib) for first-line treatment of EGFR-mutated advanced non-small cell lung cancer. The approval allows patients to transition to monthly injections as early as Week 5, significantly reducing clinic visits while maintaining consistent efficacy with the previously approved bi-weekly schedule. PALOMA-2 trial data demonstrated high objective response rates and a fivefold reduction in administration-related reactions compared to intravenous delivery.

Business News Oncology

Lilly to Acquire Orna Therapeutics in $2.4 Billion Deal to Revolutionize In Vivo Cell Therapy

Eli Lilly and Company

Eli Lilly has entered a $2.4 billion definitive agreement to acquire Orna Therapeutics. This strategic move integrates Orna’s proprietary circular RNA platform and in vivo CAR-T pipeline into Lilly’s growing portfolio, signaling a major shift toward more accessible and scalable genetic medicines for B cell-driven autoimmune diseases.

Clinical Trials News Oncology

New Real-World Data: J&J’s Erleada Slashes Risk of Death by 51% Compared to Darolutamide in Advanced Prostate Cancer

JohnsonAndJohnson

A landmark real-world analysis revealed that patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with Erleada® (apalutamide) saw a 51% lower risk of death compared to those treated with darolutamide. This data marks a significant breakthrough for patients seeking effective, “chemo-free” treatment options.

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Johnson & Johnson Announces Landmark Phase 3 Results: TECVAYLI® Reduces Risk of Disease Progression or Death by 71% in Early Relapse Multiple Myeloma

JohnsonAndJohnson

Johnson & Johnson (NYSE: JNJ) today announced groundbreaking topline results from the Phase 3 MajesTEC-9 study, demonstrating that TECVAYLI® (teclistamab-cqyv) monotherapy significantly improves outcomes for [Read More…]

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

U.S. FDA Approves AKEEGA®, the First Precision Therapy for BRCA2-Mutated Metastatic Prostate Cancer, Slashing Disease Progression Risk by 54%

JohnsonAndJohnson

A major advance in prostate cancer treatment: The FDA has approved AKEEGA® for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This first-of-its-kind precision therapy, combining niraparib and abiraterone, demonstrated a significant 54% reduction in the risk of disease progression or death compared to the standard of care. This milestone offers a personalized, highly effective option for patients with this aggressive genetic mutation.

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Lilly’s Jaypirca Outperforms Imbruvica in Landmark Phase 3 Trial for CLL/SLL

Eli Lilly and Company

Eli Lilly announced that its non-covalent BTK inhibitor, Jaypirca (pirtobrutinib), met the primary endpoint of non-inferiority on Overall Response Rate (ORR) when compared to Imbruvica (ibrutinib) in the landmark BRUIN CLL-314 Phase 3 trial. The drug demonstrated numerically higher efficacy (87.0% ORR) and a significant safety advantage, including much lower rates of atrial fibrillation/flutter and hypertension, positioning Jaypirca as a potential new front-line therapy for CLL/SLL.