Stomatitis

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Retrieved on: 
Friday, March 1, 2024

RARITAN, N.J., March 1, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that following a priority review, the U.S. Food and Drug Administration (FDA) has approved RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test.1 This FDA action converts the May 2021 accelerated approval of RYBREVANT® to a full approval based on the confirmatory Phase 3 PAPILLON study.

Key Points: 
  • The approval of RYBREVANT plus chemotherapy heralds a promising new first-line treatment option for patients newly diagnosed with non-small cell lung cancer where their driver mutation is an EGFR exon 20 insertion," said Marcia Horn**, Executive Director of the Exon 20 Group and CEO of ICAN, International Cancer Advocacy Network.
  • We've seen first-hand the extended survival that Exon 20 Group patients experienced on RYBREVANT plus chemotherapy in the PAPILLON study, and we're delighted that this historic treatment option, which specifically targets the EGFR exon 20 insertion mutation, has been approved."
  • "RYBREVANT plus chemotherapy is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations.
  • We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio."

U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

Retrieved on: 
Friday, January 19, 2024

RARITAN, N.J., Jan. 19, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.

Key Points: 
  • BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
  • This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
  • BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.
  • This model is part of the Company's ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.

Human medicines European public assessment report (EPAR): Faslodex, fulvestrant, Date of authorisation: 09/03/2004, Revision: 24, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Faslodex, fulvestrant, Date of authorisation: 09/03/2004, Revision: 24, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Faslodex, fulvestrant, Date of authorisation: 09/03/2004, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Date of authorisation: 27/11/1995, Revision: 51, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Date of authorisation: 27/11/1995, Revision: 51, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Date of authorisation: 27/11/1995, Revision: 51, Status: Authorised

Kymera Therapeutics Presents Interim Results from STAT3 Degrader Phase 1 Clinical Trial at American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 11, 2023

WATERTOWN, Mass., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today shared new data from its ongoing KT-333 Phase 1 trial. KT-333, a first-in-class, potent, highly selective, heterobifunctional small molecule degrader of STAT3, demonstrated early signs of antitumor activity at doses that were generally well-tolerated and associated with substantial STAT3 knockdown in blood and tumor. The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.

Key Points: 
  • The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.
  • The poster provides an interim update with a data cut-off as of October 18, 2023.
  • Dr. Aditi Shastri from Montefiore Medical Center and Albert Einstein College of Medicine, a lead investigator in the study, presented the interim Phase 1 findings.
  • Preclinical data demonstrating the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia was also presented at the meeting.

bluebird bio Announces FDA Approval of LYFGENIA™ (lovotibeglogene autotemcel) for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events

Retrieved on: 
Friday, December 8, 2023

LYFGENIA is a one-time gene therapy that has the potential to resolve vaso-occlusive events and is custom-designed to treat the underlying cause of sickle cell disease.

Key Points: 
  • LYFGENIA is a one-time gene therapy that has the potential to resolve vaso-occlusive events and is custom-designed to treat the underlying cause of sickle cell disease.
  • “LYFGENIA has the potential to have a transformational impact for patients who currently live under the shadow of unpredictable and debilitating vaso-occlusive events.
  • The burden associated with VOEs is pervasive and can affect every aspect of life for patients and their families and caregivers.
  • A replay of the webcast will be available on the bluebird website for 90 days following the event.

bluebird bio Details Plans for the Commercial Launch of LYFGENIA™ Gene Therapy for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events

Retrieved on: 
Friday, December 8, 2023

“Our approach is built on the principle that timely, equitable access to gene therapy is imperative for people living with sickle cell disease,” said Tom Klima, chief commercial & operating officer, bluebird bio.

Key Points: 
  • “Our approach is built on the principle that timely, equitable access to gene therapy is imperative for people living with sickle cell disease,” said Tom Klima, chief commercial & operating officer, bluebird bio.
  • The burden of sickle cell disease is immense and can impact every aspect of life for patients and their loved ones.
  • Fifty to 60% of adults living with sickle cell disease have end organ damage, and one in four people living with sickle cell disease have a stroke by age 45.
  • “The FDA approval of a sickle cell disease gene therapy may be a game changer,” said Dr. Shantel Herbert-Magee, Chief Medical Director, Louisiana Medicaid.

OGSIVEO™ (nirogacestat) Now Available from Onco360 as the First and Only FDA-Approved Treatment for Adults with Progressing Desmoid Tumors Who Require Systemic Treatment

Retrieved on: 
Thursday, November 30, 2023

Ogsiveo™ is an oral gamma secretase inhibitor for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.

Key Points: 
  • Ogsiveo™ is an oral gamma secretase inhibitor for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.
  • “Onco360 is excited to partner with the team at SpringWorks Therapeutics and become a specialty pharmacy partner for Ogsiveo™,” said Benito Fernandez, Chief Commercial Officer.
  • Desmoid tumors mostly affect people between the ages of 15 and 60 years, but they can occur at any age.
  • In children, desmoid tumors most often occur between the ages of 15 and 16 years.

TRUQAP™ (capivasertib) Now Available from Onco360

Retrieved on: 
Wednesday, November 29, 2023

Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by AstraZeneca for Truqap™ (capivasertib).

Key Points: 
  • Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by AstraZeneca for Truqap™ (capivasertib).
  • FDA also approved the FoundationOne®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.
  • “Onco360 is excited to partner with the team at AstraZeneca and become a specialty pharmacy provider for Truqap™,” said Benito Fernandez, Chief Commercial Officer.
  • “We continue to see therapeutic advancements that support our mission; to improve the lives of patients battling cancer, rare, and orphan disease.