Industry News
Read the latest news that impacts the oncology community.
Novocure’s Optune Lua® Receives CE Mark Approval for the Treatment of Metastatic Non-Small Cell Lung Cancer
Published On: April 23rd, 2025BAAR, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) announced today that Optune Lua® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen.
Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio
Published On: March 6th, 2025DUBLIN and DURHAM, N.C., March 05, 2025 (GLOBE NEWSWIRE) -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) (“Jazz” or the “Company”) and Chimerix (Nasdaq: CMRX) (“Chimerix”), today announced the companies have entered into a definitive agreement for Jazz to acquire Chimerix for $8.55 per share in cash, representing a total consideration of approximately $935 million. The transaction has been approved by both companies and is expected to close in the second quarter of 2025.
PharmaEssentia Highlights Availability of BESREMi® (ropeginterferon alfa-2b-njft) for Patients Affected by Pegasys® (peginterferon alfa-2a) Drug Shortage
Published On: March 6th, 2025BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the latest National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025, January 21, 2025) now highlight the substitution of ropeginterferon alfa-2b-njft (BESREMi®) for treating polycythemia vera (PV) in the event that peginterferon alfa-2a (Pegasys®) is unavailable.
SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
Published On: February 12th, 2025STAMFORD, Conn., Feb. 11, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has approved GOMEKLI™ (mirdametinib), SpringWorks’ MEK inhibitor, for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.1
U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for OJEMDA™ (tovorafenib) to Treat the Most Common Form of Childhood Brain Tumor in Pediatric Patients
Published On: January 22nd, 2025BOSTON, January 17, 2025 - Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
COCOON study meets primary endpoint demonstrating statistically significant and clinically meaningful reduction in dermatologic reactions with easy-to-use prophylactic regimen for patients with EGFR-mutated NSCLC
Published On: January 22nd, 2025The first interim analysis of the Phase 2 COCOON study met its primary endpoint, demonstrating that an easy-to-use and readily available regimen significantly reduced the frequency of moderate-to-severe skin and nail side effects (Grade 2 or higher) and severity of skin-related side effects compared to standard dermatological management in patients receiving first-line treatment with RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib).
New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
Published On: January 16th, 2025RARITAN, N.J., January 15, 2025 – Johnson & Johnson (NYSE: JNJ) announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) shows statistically significant and clinically meaningful improvement in overall survival versus osimertinib
Published On: January 8th, 2025RARITAN, N.J., January 7, 2025 – Johnson & Johnson (NYSE:JNJ) today announced positive topline results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study, evaluating RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
Published On: December 23rd, 2024NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.i
Lilly’s Imlunestrant, an Oral SERD, Significantly Improved Progression-Free Survival as Monotherapy and in Combination with Verzenio® (abemaciclib) in Patients with ER+, HER2- Advanced Breast Cancer
Published On: December 12th, 2024INDIANAPOLIS, Dec. 11, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results from the Phase 3 EMBER-3 study of imlunestrant, an investigational, oral selective estrogen receptor degrader (SERD), in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC), whose disease progressed on a prior aromatase inhibitor (AI), with or without a CDK4/6 inhibitor. Imlunestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as monotherapy in patients with an ESR1 mutation versus standard of care endocrine therapy (SOC ET), reducing the risk of disease progression or death by 38%.
