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Jazz Pharmaceuticals Announces Ziihera® (zanidatamab-hrii) Investor Webcast on December 11, 2024

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Jazz Pharmaceuticals (Nasdaq: JAZZ) announced a webcast scheduled for December 11, 2024, at 4:30 p.m. ET to discuss Ziihera® (zanidatamab-hrii), their recently approved chemotherapy-free dual HER2-targeted bispecific antibody for biliary tract cancer (BTC). The presentation will cover clinical data, patient needs, and commercialization strategy.

The FDA granted accelerated approval to Ziihera on November 20, 2024, for treating adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC. Dr. Shubham Pant from MD Anderson Cancer Center will discuss data from the HERIZON-BTC-01 trial during the webcast.

Jazz Pharmaceuticals (Nasdaq: JAZZ) ha annunciato un webcast programmato per l'11 dicembre 2024, alle 16:30 ET, per discutere di Ziihera® (zanidatamab-hrii), il loro recente anticorpo bispecifico duale mirato a HER2, che non prevede chemioterapia, per il cancro delle vie biliari (BTC). La presentazione tratterà dati clinici, bisogni dei pazienti e strategie di commercializzazione.

La FDA ha concesso l'approvazione accelerata a Ziihera il 20 novembre 2024, per il trattamento di adulti precedentemente trattati con BTC HER2-positivo (IHC 3+) non resecabile o metastatico. Il Dr. Shubham Pant del MD Anderson Cancer Center discuterà i dati del trial HERIZON-BTC-01 durante il webcast.

Jazz Pharmaceuticals (Nasdaq: JAZZ) anunció una transmisión programada para el 11 de diciembre de 2024 a las 4:30 p.m. ET para discutir Ziihera® (zanidatamab-hrii), su anticuerpo bispecífico dual dirigido a HER2 recientemente aprobado y sin quimioterapia para el cáncer de vías biliares (BTC). La presentación cubrirá datos clínicos, necesidades de los pacientes y estrategia de comercialización.

La FDA otorgó la aprobación acelerada a Ziihera el 20 de noviembre de 2024, para tratar a adultos previamente tratados con BTC HER2 positivo (IHC 3+) irresecable o metastásico. El Dr. Shubham Pant del MD Anderson Cancer Center discutirá los datos del ensayo HERIZON-BTC-01 durante la transmisión.

재즈 제약 (Nasdaq: JAZZ)는 2024년 12월 11일 오후 4:30 ET에 웹캐스트를 개최하여 최근 승인된 이중 HER2 타겟화 비스페시픽 항체인 지히라® (자니다탐맙-hrii)에 대해 논의할 것이라고 발표했습니다. 이 약물은 담관암(BTC) 치료에 화학요법 없이 사용됩니다. 발표에서는 임상 데이터, 환자 요구사항 및 상업화 전략을 다룰 예정입니다.

FDA는 2024년 11월 20일에 재수술이 불가능한 또는 전이성 HER2 양성 (IHC 3+) BTC를 치료하기 위해 Ziihera에 대해 가속 승인을 부여했습니다. MD 앤더슨 암 센터의 Dr. Shubham Pant는 웹캐스트 중 HERIZON-BTC-01 시험의 데이터를 논의할 것입니다.

Jazz Pharmaceuticals (Nasdaq: JAZZ) a annoncé un webinaire prévu pour le 11 décembre 2024 à 16h30 ET pour discuter de Ziihera® (zanidatamab-hrii), leur anticorps bispécifique dual récemment approuvé, ciblant HER2 et sans chimiothérapie, pour le cancer des voies biliaires (BTC). La présentation couvrira des données cliniques, les besoins des patients et la stratégie de commercialisation.

La FDA a accordé une approbation accélérée à Ziihera le 20 novembre 2024 pour traiter les adultes ayant déjà reçu un traitement pour BTC HER2-positif (IHC 3+) non résécable ou métastatique. Le Dr Shubham Pant du MD Anderson Cancer Center discutera des données de l'essai HERIZON-BTC-01 lors du webinaire.

Jazz Pharmaceuticals (Nasdaq: JAZZ) kündigte ein Webcast am 11. Dezember 2024 um 16:30 Uhr ET an, um Ziihera® (zanidatamab-hrii), ihren kürzlich genehmigten chemotherapie-freien dualen HER2-zielgerichteten bispezifischen Antikörper zur Behandlung von Gallengangkrebs (BTC), zu besprechen. Die Präsentation wird klinische Daten, Patientenbedürfnisse und die Vermarktungsstrategie behandeln.

Die FDA erteilte am 20. November 2024 eine beschleunigte Zulassung für Ziihera zur Behandlung von Erwachsenen mit zuvor behandelten, nicht resektablen oder metastasierenden HER2-positiven (IHC 3+) BTC. Dr. Shubham Pant vom MD Anderson Cancer Center wird während des Webcasts Daten aus der HERIZON-BTC-01-Studie vorstellen.

Positive
  • FDA granted accelerated approval for Ziihera, expanding Jazz's oncology portfolio
  • First chemotherapy-free dual HER2-targeted bispecific antibody for BTC treatment
Negative
  • None.

DUBLIN, Dec. 4, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that it will host a webcast on Wednesday, December 11, 2024, at 4:30 p.m. ET / 9:30 p.m. GMT to provide an overview of clinical data, patient need and commercialization strategy for Ziihera® (zanidatamab-hrii), the first chemotherapy-free dual HER2-targeted bispecific antibody indicated for biliary tract cancer (BTC). Ziihera was approved under accelerated approval by the U.S. Food and Drug Administration (FDA) on November 20, 2024, for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC, as detected by an FDA-approved test.1 

Jazz senior management will provide an overview of Ziihera and commercial launch plans, and Dr. Shubham Pant will discuss previously disclosed BTC data from the HERIZON-BTC-01 trial. Shubham Pant, M.D., MBBS, is a professor in the Department of Gastrointestinal Medical Oncology with a joint appointment in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.

Audio webcast/conference call: 
U.S. Dial-In Number: +1 800 715 9871
Ireland Dial-In Number: +353 1800 943 926
Additional global dial-in numbers are available here.
Passcode: 4898380

Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at https://investor.jazzpharma.com/investors/events-presentations. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.

A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at https://investor.jazzpharma.com/investors/events-presentations

About Ziihera® (zanidatamab-hrii)
Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1 

Zanidatamab is not approved anywhere else in the world.

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule. 

The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. 

Important Safety Information


WARNING: EMBRYO-FETAL TOXICITY 
Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity
ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA.

Left Ventricular Dysfunction

ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients.

Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions.

The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%.

Infusion-Related Reactions
ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day.

Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use.

If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs.

Diarrhea

ZIIHERA can cause severe diarrhea.

Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity.

ADVERSE REACTIONS

Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA.

The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%).

USE IN SPECIFIC POPULATIONS

Pediatric Use

Safety and efficacy of ZIIHERA have not been established in pediatric patients.

Geriatric Use

Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older.

No overall differences in safety or efficacy were observed between these patients and younger adult patients.

About Jazz Pharmaceuticals 
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Contacts:

Investors:
Jeff Macdonald
Executive Director, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717

Media:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948

References:

1ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

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SOURCE Jazz Pharmaceuticals plc

FAQ

When did Jazz Pharmaceuticals (JAZZ) receive FDA approval for Ziihera?

Jazz Pharmaceuticals received FDA accelerated approval for Ziihera on November 20, 2024.

What is the approved indication for Jazz Pharmaceuticals' Ziihera?

Ziihera is approved for treating adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.

When is Jazz Pharmaceuticals (JAZZ) hosting the Ziihera investor webcast?

Jazz Pharmaceuticals is hosting the Ziihera investor webcast on December 11, 2024, at 4:30 p.m. ET / 9:30 p.m. GMT.

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