Story · Medicine & Biotech
FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma
8 outlets · first reported by FDA Press Announcements 6d ago · latest 1d ago · 111 hours of coverage · 3 countries
Coverage, in order
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6d agoFDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma
The U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherap
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6d agoFDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck squamous cell carcinoma
FDA granted accelerated approval to amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody.
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5d agoJ&J's Rybrevant Faspro moves beyond lung cancer with FDA nod
J&J's Rybrevant Faspro moves beyond lung cancer with FDA nod Phil.Taylor Fri, 06/11/2026 - 09:41
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5d ago
FDA Approves Dual-Targeted Therapy for Head and Neck Cancer(MedPage Today) -- The FDA granted accelerated approval to subcutaneous amivantamab and hyaluronidase (Rybrevant Faspro) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma. The approved indication is...
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5d ago
FDA approves Rybrevant Faspro for metastatic head, neck cancerThe FDA granted accelerated approval for amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck cancer based on findings showing twice the response rate of previously approved therapies, Johnson & Johnson announced. Subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant…
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5d ago
Bispecific J&J Drug Wins Speedy FDA Approval for Treating Head & Neck CancerAccelerated FDA approval of Johnson & Johnson’s Rybrevant Faspro covers advanced cases of head and neck cancer. The bispecific antibody was initially approved for treating certain lung cancers.
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5d agoFDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection
On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients
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5d agoFDA approves lazertinib with amivantamab-vmjw for non-small lung cancer
On August 19, 2024, the FDA approved lazertinib (Lazcluze, Janssen Biotech, Inc.) in combination with amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).
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5d agoFDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia
On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.
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5d agoFDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer
On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.
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5d agoFDA approves durvalumab for limited-stage small cell lung cancer
On December 4, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
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5d agoFDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.).
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5d agoFDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications
On March 1, 2024, the FDAapproved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
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5d agoFDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations
On September 19, 2024, the FDA approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer.
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5d agoFDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
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5d agoFDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors
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4d ago
Joanna Sadowska: FDA Approves J&J’s Dual-Targeted Therapy for Head and Neck CancerJoanna Sadowska, Director of Clinical Solutions at Biorce, shared on LinkedIn: “Breaking News – FDA approves J&J’s dual-targeted cancer therapy after 42% response rate in head and neck cancer Johnson &
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4d ago
Emrullah Yilmaz։ FDA Grants Accelerated Approval to Rybrevant Faspro for Head and Neck Squamous Cell CarcinomaEmrullah Yilmaz, Senior Medical Director at Johnson & Johnson Innovative Medicine, shared on LinkedIn: “Big news for the head and neck cancer community. Today, the FDA granted accelerated approval to
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3d ago
FDA Grants Accelerated Approval to New Treatment for Head and Neck Squamous Cell CarcinomaThe U.S. Food and Drug Administration has granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy…
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2d ago
Cesar Perez: FDA Grants Accelerated Approval to Amivantamab for Recurrent or Metastatic HNSCCCesar Perez, Director of Drug Development at Lake Nona DDU of Florida Cancer Specialists and Research Institute, shared The Food and Drug Administration (FDA)’s post on LinkedIn, adding: “Huge news
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2d agoFDA approves tepotinib for metastatic non-small cell lung cancer
On February 15, 2024, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
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2d agoFDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
On April 29, 2024, the Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received acce
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1d ago
FDA Grants Accelerated Approval to the First EGFR/MET-Targeted Therapy for HNSCC – The Babak LabThe Babak Lab shared on LinkedIn: “FDA grants accelerated approval to the first EGFR/MET-targeted therapy for advanced head and neck cancer. The FDA has approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
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1d agoFDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer
FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer
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1d agoFDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
On September 25, 2024, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer.
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1d agoFDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancer
On January 26, 2023, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).
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1d agoFDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer
On January 12, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.
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1d agoFDA approves repotrectinib for ROS1-positive non-small cell lung cancer
On November 15, 2023, the Food and Drug Administration approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
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1d agoFDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation
FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation
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1d agoFDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer
On August 15, 2024, the FDA approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer.
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1d agoFDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
On October 3, 2024, the FDA approved neoadjuvant/adjuvant nivolumab with platinum-doublet chemotherapy for resectable non-small cell lung cancer.
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1d agoFDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer
On October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-sm
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