On October 8, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported it will present data on its investigational BTK inhibitor zanubrutinib and its investigational PARP inhibitor pamiparib at two upcoming medical meetings (Press release, BeiGene, OCT 8, 2018, View Source;p=irol-newsArticle&ID=2370698 [SID1234529823]).

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Zanubrutinib clinical data will be included in an oral presentation at the 10th International Workshop on Waldenström’s Macroglobulinemia (IWWM). The IWWM meeting is taking place in New York City from October 11th to 13th, 2018.

Pamiparib clinical data will be included in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, which will take place October 19th to 23rd in Munich, Germany.

IWWM Oral Presentation:

Title: Improved Depth of Response With Increased Follow-up in Phase 1 Trial of Patients with Waldenström Macroglobulinemia (WM) Treated With Oral Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib (BGB-3111)
Session ID: Session X
Location: Main Area
Date: October 12, 2018
Time: 12:45 pm ET
Presenter: Constantine Tam, M.D., Director of Hematology, St. Vincent’s Hospital and Consultant Hematologist, Peter MacCallum Cancer Center

ESMO Poster Presentation:

Title: Preliminary Results of Pamiparib (BGB-290), a PARP1/2 Inhibitor, in Combination with Temozolomide (TMZ) in Patients With Locally Advanced or Metastatic Solid Tumors
Presentation #: 421P
Session ID: Poster display session (ID 258)
Location: Hall A3 – Poster Area Networking Hub
Date: October 22, 2018
Time: 13:15 to 14:15 CEST
Presenter: Melissa Johnson, M.D., Associate Director, Lung Cancer Research Program, Sarah Cannon Research Institute
About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various lymphomas.

About Pamiparib
Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists in Beijing, pamiparib is currently in global clinical development as a monotherapy and in combination with other agents for a variety of solid tumor malignancies.

On October 8, 2018 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Quality Affordable Healthcare Products, reported the appointment of Murray S. Kessler as President, CEO and member of the Board of Directors, effective immediately (Press release, Perrigo Company, OCT 8, 2018, View Source [SID1234529832]).

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Chairman of the Board of Directors, Rolf Classon, stated, "We are excited to have Murray Kessler, a highly successful business executive, join Perrigo as its next CEO. Given the decision to separate the Rx pharmaceuticals business and pursue a consumer-focused strategy, the Board is looking forward to partnering with him to develop Perrigo’s strategic plan. Murray joins Perrigo with more than 30 years of leadership experience in growing consumer products companies and managing businesses in a regulated environment. He has advanced corporate strategy through innovation, inorganic opportunities, and continuous portfolio improvement. We are confident that his track record in driving shareholder value and running highly successful businesses will advance Perrigo’s consumer strategy and help the Company deliver on our commitments to consumers and customers."

Mr. Kessler most recently served as the Chairman of the Board of Directors and CEO of Lorillard Tobacco Company (2010-2015). As a leading innovator in the industry, Mr. Kessler spearheaded the company’s expansion into new and emerging categories, growing Lorillard’s market capitalization from approximately $9 billion to approximately $28 billion during his tenure. Prior to joining Lorillard, Mr. Kessler served as Vice Chair of Altria, Inc. and President and CEO of UST Inc., a wholly owned subsidiary of Altria since 2009. Mr. Kessler originally joined UST in 2000 and was promoted to the role of President of the division within one year. In 2005, Mr. Kessler was appointed COO of UST, and served as CEO from 2007 to 2009. During his tenure, market capitalization grew from approximately $2.5 billion to approximately $12.7 billion.

Before joining UST, Mr. Kessler had more than 18 years of consumer packaged goods experience with several well-known consumer companies, including Vlasic Foods International, Campbell Soup Company and The Clorox Company. He earned a Bachelor of Business Administration degree from Villanova University and a Master of Business Administration degree from the New York University Stern School of Business.

Newly appointed CEO and President of Perrigo, Murray Kessler, commented, "This is a rare opportunity to drive winning results with a passionate and committed team in a high potential, consumer focused company that holds a leadership position in a broad portfolio of sizeable and recognizable categories. My experience in working with highly regulated consumer products reinforces my belief in this opportunity and it is for these reasons that I have chosen to once again take on the deep commitment of being a public company CEO. I look forward to working with the talented Perrigo leadership team and the Board to put a plan in place that delivers long-term sustainable and reliable growth."

Mr. Classon concluded, "The Board and Uwe mutually agreed the transition was in the best interest of the Company and, given the previously announced separation of the Rx business, now is the appropriate time to make this change. The Board determined that Murray is the right CEO for Perrigo’s consumer focused strategy going forward. We are thankful for Uwe’s leadership, including the decision to separate the Rx business. We are grateful for his service and wish him the best in his future endeavours."

Mr. Roehrhoff stepped down as President, CEO and board member and will make himself available to ensure a smooth and successful transition

On October 8, 2018 Exelixis, Inc. (NASDAQ:EXEL) reported that data from clinical trials of cabozantinib will be the subject of 13 presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, which is being held October 19-23, 2018 in Munich, Germany (Press release, Exelixis, OCT 8, 2018, View Source;p=irol-newsArticle&ID=2370700 [SID1234529822]).

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Poster presentations will include results from the dose escalation stage of the phase 1b COSMIC-021 study of cabozantinib in combination with atezolizumab in previously untreated advanced renal cell carcinoma (RCC). Additionally, a poster discussion session will feature a late-breaking abstract evaluating the effect of PD-L1 status on clinical outcomes with cabozantinib in advanced RCC in the CABOSUN and METEOR trials.

"The data at ESMO (Free ESMO Whitepaper) showcase the potential of cabozantinib across a range of difficult-to-treat cancers," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "We are especially excited to present results from the dose escalation stage of the COSMIC-021 trial evaluating the combination of cabozantinib and atezolizumab in advanced kidney cancer and look forward to sharing these data and more with the oncology community at this year’s ESMO (Free ESMO Whitepaper) Congress."

Cabozantinib to be featured in 13 presentations
The full schedule of cabozantinib presentations expected at the meeting is as follows:

Proffered Paper Session

[Abstract LBA67] "Cabozantinib in Patients with Advanced Osteosarcomas and Ewing Sarcomas: a French Sarcoma Group (FSG)/ US National Cancer Institute Phase II Collaborative Study"
Antoine Italiano, M.D., Ph.D., Early Phase Trials Unit, Institut Bergonié, Bordeaux, France
Session: Sarcoma
Proffered Paper Session Friday, October 19, 2:00 – 3:30 PM CEST, Hall B3 – Room 21

Poster Discussion

[Abstract LBA34] "PD-L1 Status and Clinical Outcomes to Cabozantinib, Sunitinib and Everolimus in Patients with Metastatic Clear-Cell RCC Treated on CABOSUN and METEOR Clinical Trials"
Toni K. Choueiri, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Session: Genitourinary Tumors, Non Prostate
Poster Discussion Session Saturday, October 20, 2:45 – 4:05 PM, CEST, ICM – Room 1

[Abstract 1310PD] "Prospective Genome and Transcriptome Sequencing in Advanced-Stage Neuroendocrine Neoplasms"
Leonidas Apostolidis, M.D., National Center for Tumor Diseases (NCT), Heidelberg, Germany
Session: NETs
Poster Discussion Session Monday, October 22, 11:00 AM – 12:15 PM CEST, Hall B3 – Room 22

Poster Presentations

[Abstract 702P] "Outcomes by Baseline Alpha-Fetoprotein (AFP) Levels in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Previously Treated Advanced Hepatocellular Carcinoma (HCC)"
R. K. Kelley, M.D., University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 703P] "Assessment of Disease Burden in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Advanced Hepatocellular Carcinoma (HCC)"
Jean Frederic Blanc, M.D., Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 704P] "Outcomes by Prior Transarterial Chemoembolization (TACE) in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Patients (pts) with Advanced Hepatocellular Carcinoma (HCC)"
Thomas Yau, M.D., Queen Mary Hospital, Hong Kong, China
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 1829TiP] "A Noninferiority Trial of Cabozantinib (C) Comparing 60 mg vs 140 mg Orally per Day to Evaluate the Efficacy and Safety in Patients (pts) with Progressive, Metastatic Medullary Thyroid Cancer (MTC)"
Jolanta Krajewska, M.D., Ph.D., M. Sklodowska-Curie Institute – Oncology Center, Gliwice, Poland
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 1913P] "A Guided and Personnalized Treatment in Metastatic Breast Cancer: Optimisation of Gene and Protein Expression in Tumor Tissue"
Emmanuel Seront, M.D., Cliniques Universitaires Saint-Luc King Albert II Institute, Brussels, Belgium
Session: Poster Display Session
Poster presented Sunday, October 21, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 872P] "Phase 1b Study (COSMIC-021) of Cabozantinib in Combination with Atezolizumab: Results of the Dose Escalation Stage in Patients (pts) with Treatment-Naïve Advanced Renal Cell Carcinoma (RCC)"
Neeraj Agarwal, M.D., Huntsman Cancer Center, Salt Lake City, Utah, USA
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 893P] "Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC): Data from UK Expanded Access Program (EAP)"
Alfonso Gomez de Liano Lista, M.D., Barts Cancer Institute, London, England
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 879P] "Activity of Cabozantinib (cabo) after PD-1/PD-L1 Immune Checkpoint Blockade (ICB) in Metastatic Clear Cell Renal Cell Carcinoma (mccRCC)"
Bradley A. McGregor, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 882P] "Potent Natural Killer (NK) and Myeloid Blood Cell Remodeling by Cabozantinib (Cabo) in Pretreated Metastatic Renal Cell Carcinoma (mRCC) Patients (pts)"
Elena Verzoni, M.D., Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

[Abstract 889P] "Clinical Outcomes of Patients with Metastatic Renal Cell Carcinoma (mRCC) Treated with Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitors (TKI) and Mammalian Target of Rapamycin Inhibitors (mTORI) after Immuno-oncology (IO) Checkpoint Inhibitors"
Jeffrey Graham, M.D., Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada
Session: Poster Display Session
Poster presented Monday, October 22, 12:45 – 1:45 PM CEST, Hall A3 – Poster Area Networking Hub

About CABOMETYX (cabozantinib)

CABOMETYX tablets are approved in the United States for the treatment of patients with advanced RCC. CABOMETYX tablets are also approved in the European Union, Norway, Iceland, Australia, Switzerland, South Korea and Canada for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy, and in the European Union for previously untreated intermediate- or poor-risk advanced RCC. In March 2017, the FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC. In May 2018, the FDA accepted Exelixis’ supplemental New Drug Application for CABOMETYX as a treatment for patients with previously treated HCC and assigned it a Prescription Drug User Fee Act action date of January 14, 2019. On March 28, 2018, Ipsen announced that the European Medicines Agency validated its application for a new indication for cabozantinib as a treatment for previously treated advanced HCC in the European Union; on September 20, 2018 the CHMP provided a positive opinion for CABOMETYX as a monotherapy for the treatment of HCC in adults who have been previously treated with sorafenib. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan.

U.S. Important Safety Information

Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In two RCC studies, the incidence of Grade ≥ 3 hemorrhagic events was 3% in CABOMETYX-treated patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: In RCC studies, fistulas were reported in 1% of CABOMETYX-treated patients. Fatal perforations occurred in patients treated with CABOMETYX. In RCC studies, gastrointestinal (GI) perforations were reported in 1% of CABOMETYX-treated patients. Monitor patients for symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula which cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. In RCC studies, venous thromboembolism occurred in 9% (including 5% pulmonary embolism) and arterial thromboembolism occurred in 1% of CABOMETYX-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension, including hypertensive crisis. In RCC studies, hypertension was reported in 44% (18% Grade ≥ 3) of CABOMETYX-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.
Diarrhea: In RCC studies, diarrhea occurred in 74% of patients treated with CABOMETYX. Grade 3 diarrhea occurred in 11% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Palmar-Plantar Erythrodysesthesia (PPE): In RCC studies, palmar-plantar erythrodysesthesia (PPE) occurred in 42% of patients treated with CABOMETYX. Grade 3 PPE occurred in 8% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity may be associated with CABOMETYX. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during CABOMETYX treatment and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, vomiting, dysgeusia, and stomatitis.
Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
Lactation: Advise women not to breastfeed while taking CABOMETYX and for 4 months after the final dose.
Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

On October 8, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that additional clinical results from PROCLAIM-072, an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, will be presented at the 2018 Annual Meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) (Press release, CytomX Therapeutics, OCT 8, 2018, View Source [SID1234529821]). The conference will take place from October 19-23 in Munich, Germany.

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Two posters will provide additional results from the ongoing monotherapy dose escalation arm and the combination arm with Yervoy (ipilimumab) of the PROCLAIM-CX-072 trial, each in patients with advanced unresectable solid tumors.

CytomX’s ESMO (Free ESMO Whitepaper) poster presentations will include longer follow-up periods from additional patients treated in both the monotherapy and combination arms, new patient data from the combination arm and will reflect a data cutoff approximately three months after the abstract data cutoff.

Poster 435P – Preliminary Results of PROCLAIM-CX-072: The First-In-Human, Dose-Finding Trial of PD-L1 Probody Therapeutic CX-072 as Monotherapy in Patients with Advanced Solid Tumors
Presenter: Valentina Boni, M.D., Ph.D., START Madrid-CIOCC HM University Hospital Sanchinarro, Madrid, Spain
Date/Time: Monday, October 22, 12:45 p.m. – 1:45 p.m. CEST/ 6:45 a.m. – 7:45 a.m. EDT
Location: Hall A3

Poster 436P – Preliminary Results of the First-In-Human, Dose-Finding PROCLAIM-CX-072 Trial Evaluating the PD-L1 Probody Therapeutic CX-072 in Combination with Ipilimumab in Patients with Advanced Solid Tumors
Presenter: Ruth Plummer, M.D., Northern Centre for Cancer Care, Newcastle, United Kingdom
Date/Time: Monday, October 22, 12:45 p.m. – 1:45 p.m. CEST/ 6:45 a.m. – 7:45 a.m. EDT
Location: Hall A3

Poster abstracts can be located by searching The ESMO (Free ESMO Whitepaper) 2018 Online Program Session and using the Poster numbers above.

CytomX’s posters will be available online under the Events and Presentations section of the CytomX website at the time of presentation at www.CytomX.com.

Conference Call and Webcast

CytomX will host a conference call and webcast to discuss these presentations on Monday, October 22, 2018 at 2:30 p.m. CEST/ 8:30 a.m. EDT. Participants can dial 1-877-809-6037 U.S. Toll Free or 1-615-247-0221 International using the Conference ID: 1275596.

A live webcast can be accessed under the Events and Presentations Section of CytomX’s Investor Relations section at View Source Access the website 15 minutes prior to the start of the call to download and install any necessary audio software and slides. A replay of the webcast will be archived and available on CytomX’s website for 30 days following the event.

About PROCLAIM

PROCLAIM (Probody Clinical Assessment In Man) is an international umbrella program designed to evaluate CytomX Probody therapeutics. The first module is the PROCLAIM-072 clinical program, an open-label, dose-finding Phase 1/2 trial evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with metastatic or locally advanced unresectable solid tumors or lymphomas. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients, and potentially improves safety, particularly in the combination setting.

Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.

Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical models.

On October 8, 2018 Exelixis, Inc. (Nasdaq: EXEL) reported the initiation of a phase 3 pivotal trial (COSMIC-311) of single-agent cabozantinib in patients with radioiodine-refractory differentiated thyroid cancer (DTC) who have progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies (Press release, Exelixis, OCT 8, 2018, View Source;p=irol-newsArticle&ID=2370576 [SID1234529814]). The co-primary endpoints for the trial are progression-free survival and objective response rate.

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"Cabozantinib has demonstrated encouraging clinical activity in patients with radioiodine-refractory differentiated thyroid cancer in phase 1 and 2 studies, suggesting it may be a promising treatment option for patients who have progressed after prior VEGFR-targeting therapy," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "We look forward to enrolling patients in this global trial to learn more about the potential of cabozantinib for this intractable form of thyroid cancer."

COSMIC-311 is a multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that aims to enroll approximately 300 patients at approximately 150 sites globally. Patients will be randomized in a 2:1 ratio to receive either cabozantinib 60 mg or placebo once daily.

"With the incidence of thyroid cancer increasing more rapidly than any other type of cancer in the U.S., and limited options available to patients whose disease has progressed following anti-VEGFR therapy, there is an urgent need for new treatments," said Marcia Brose, M.D., Ph.D., Associate Professor of Otorhinolaryngology: Head and Neck Surgery and Director of the Center for Rare Cancers and Personalized Therapy at the Abramson Cancer Center of the University of Pennsylvania, and principal investigator of the trial. "Given the positive results from earlier stage trials, we are eager to learn more from this phase 3 study about cabozantinib’s potential benefit in this patient population."

More information about this trial is available at ClinicalTrials.gov.

About Differentiated Thyroid Carcinoma

Thyroid cancer is commonly diagnosed at a younger age than most other adult cancers and is the most rapidly increasing cancer in the U.S., tripling in incidence in the past three decades.1 Approximately 54,000 new cases of thyroid cancer will be diagnosed in the U.S. in 2018.1 Nearly three out of four of these cases will be in women.1 Cancerous thyroid tumors include differentiated, medullary and anaplastic forms.1

Differentiated thyroid tumors, which make up about 90 percent of all thyroid cancers, are typically treated with surgery followed by ablation of the remaining thyroid with radioiodine.2 Approximately 5 to 15 percent of differentiated thyroid tumors are resistant to radioiodine treatment.3 For these patients, life expectancy is only three to six years from the time metastatic lesions are detected.4,5,6

About CABOMETYX (cabozantinib)

CABOMETYX tablets are approved in the United States for the treatment of patients with advanced RCC. CABOMETYX tablets are also approved in: the European Union, Norway, Iceland, Australia, Switzerland and South Korea for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy; in the European Union for previously untreated intermediate- or poor-risk advanced RCC; and in Canada for adult patients with advanced RCC who have received prior VEGF targeted therapy. In March 2017, the FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC. In May 2018, the FDA accepted Exelixis’ supplemental New Drug Application for CABOMETYX as a treatment for patients with previously treated HCC and assigned it a Prescription Drug User Fee Act action date of January 14, 2019. On March 28, 2018, Ipsen announced that the European Medicines Agency validated its application for a new indication for cabozantinib as a treatment for previously treated advanced HCC in the European Union; on September 20, 2018 the CHMP provided a positive opinion for CABOMETYX as a monotherapy for the treatment of HCC in adults who have been previously treated with sorafenib. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan.

CABOMETYX is not indicated for radioiodine-refractory DTC.

Please see Important Safety Information below and full U.S. prescribing information at View Source

U.S. Important Safety Information

Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In two RCC studies, the incidence of Grade ≥ 3 hemorrhagic events was 3% in CABOMETYX-treated patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: In RCC studies, fistulas were reported in 1% of CABOMETYX-treated patients. Fatal perforations occurred in patients treated with CABOMETYX. In RCC studies, gastrointestinal (GI) perforations were reported in 1% of CABOMETYX-treated patients. Monitor patients for symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula which cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. In RCC studies, venous thromboembolism occurred in 9% (including 5% pulmonary embolism) and arterial thromboembolism occurred in 1% of CABOMETYX-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension, including hypertensive crisis. In RCC studies, hypertension was reported in 44% (18% Grade ≥ 3) of CABOMETYX-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.
Diarrhea: In RCC studies, diarrhea occurred in 74% of patients treated with CABOMETYX. Grade 3 diarrhea occurred in 11% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Palmar-Plantar Erythrodysesthesia (PPE): In RCC studies, palmar-plantar erythrodysesthesia (PPE) occurred in 42% of patients treated with CABOMETYX. Grade 3 PPE occurred in 8% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity may be associated with CABOMETYX. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during CABOMETYX treatment and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, vomiting, dysgeusia, and stomatitis.
Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
Lactation: Advise women not to breastfeed while taking CABOMETYX and for 4 months after the final dose.
Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment