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Daiichi Sankyo Selects Lead Candidate Built on Zymeworks’ Azymetric™ Bispecific Platform

On April 25, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and Daiichi Sankyo Company, Limited ("Daiichi Sankyo") reported that Daiichi Sankyo has exercised its option for a commercial license to a proprietary immuno-oncology bispecific built on Zymeworks’ Azymetric and EFECT platforms (Press release, Zymeworks, APR 25, 2019, https://www.businesswire.com/news/home/20190425005026/en/Daiichi-Sankyo-Selects-Lead-Candidate-Built-Zymeworks%E2%80%99 [SID1234535399]). Zymeworks will receive a US$3.5 million payment based on Daiichi Sankyo’s selection of the first of up to three lead product candidates under its collaboration agreements with Zymeworks.

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"This is another example of how our Azymetric platform can facilitate the rapid selection and development of bispecific antibody candidates for our pharmaceutical partners," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "We are thrilled to see Daiichi Sankyo move this novel therapeutic program into late-stage preclinical development. This is an important step forward towards our shared goal of improving the standard of care for patients with cancer."

"Our partnership with Zymeworks has allowed us to develop therapeutic candidates based on complex mechanisms of action such as immune cell engagement," said Antoine Yver, M.D., M.Sc., Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "Through this partnership, we have identified a novel bispecific therapeutic that we are excited to be advancing towards the clinic. We look forward to continuing our strong partnership with Zymeworks to develop novel therapeutic options for patients with cancer worldwide."

Under the terms of the 2016 cross-licensing and collaboration agreement, Zymeworks granted Daiichi Sankyo a license to Zymeworks’ Azymetric and EFECT platforms to develop a bispecific antibody therapeutic for which Zymeworks is eligible to receive further clinical and commercial milestone payments of up to US$143.4 million, as well as up to double-digit tiered royalties on global product sales. Additionally, Zymeworks obtained a license to certain immuno-oncology antibodies from Daiichi Sankyo, with the right to research, develop, and commercialize multiple bispecific products globally in exchange for royalties on global product sales.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life, and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

About the EFECT Platform

The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up- and down-regulation of effector functions. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization of therapeutic responses for different diseases.

Odonate Therapeutics Announces Financial Results for the Three Months Ended March 31, 2019

On April 25, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three months ended March 31, 2019 (Press release, Odonate Therapeutics, APR 25, 2019, View Source [SID1234535398]).

As of March 31, 2019, Odonate had $112.1 million in cash, compared to $139.1 million as of December 31, 2018. This decrease in cash resulted primarily from net cash used in operating activities of $27.1 million. Odonate’s net loss for the three months ended March 31, 2019 was $28.6 million, or $1.16 per share, compared to $16.9 million, or $0.69 per share, for the same period in 2018.

"In the first quarter of 2019, we expanded the development of tesetaxel by initiating two new clinical studies, CONTESSA 2 and CONTESSA TRIO, the first study to investigate tesetaxel in combination with PD-(L)1 inhibitors," said Kevin Tang, Chief Executive Officer of Odonate. "We continue to expect to complete enrollment in CONTESSA, our ongoing multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with metastatic breast cancer, in the second half of 2019 and report top-line results in 2020."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of multiple studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with locally advanced or metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC. To learn more, please visit www.contessastudy.com.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive LA/MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system metastases are eligible for both cohorts.

Pacira to Report First Quarter 2019 Financial Results on Thursday May 2, 2019

On April 25, 2019 Pacira BioSciences, Inc. (NASDAQ:PCRX) reported that it will report its first quarter financial results before the open of the U.S. markets on Thursday, May 2, 2019 (Press release, Pacira Pharmaceuticals, APR 25, 2019, View Source;p=irol-newsArticle&ID=2395693 [SID1234535397]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

To participate in the conference call, dial 1-877-845-0779 and provide the passcode 9776218. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 9776218. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

MATEON AND ONCOTELIC COMPLETE THEIR MERGER AND CREATE A NEW IMMUNO-ONCOLOGY COMPANY WITH A LATE-STAGE CLINICAL ASSET AGAINST CANCER AND A PROMISING PRODUCT PIPELINE

On April 25, 2019 Mateon Therapeutics, Inc. (OTCQB:MATN) and Oncotelic Inc. reported that they have completed their previously announced merger (Press release, Mateon Therapeutics, APR 25, 2019, View Source [SID1234535396]). The combined company has a focused pipeline of TGF-β RNA Therapeutics for late stage cancers, including gliomas, pancreatic cancer and melanoma.

In connection with the merger, Oncotelic, Inc. has become a wholly owned subsidiary of Mateon, with the former Oncotelic shareholders receiving a combination of common and preferred stock in Mateon representing approximately 85% of Mateon’s outstanding equity. Mateon’s prior stockholders retain approximately 15% of the outstanding equity. In addition, Mateon stockholders of record as of April 18, 2019 received a contingent value right (CVR) related to Mateon’s drug candidates OXi4503 and CA4P. CVR holders are entitled to receive 75% of the net proceeds in excess of $0.5 million from a sale of assets relating to these two drug candidates for a four-year period following the merger. The CVRs will not be registered to trade on any stock exchange, and new discoveries related to these drug candidates are not subject to payment obligations under the CVR.

Upon the closing of the merger, Dr. Vuong Trieu was appointed Chief Executive Officer and Dr. Fatih Uckun was appointed Chief Medical Officer of Mateon. Matthew M. Loar remains the Company’s Chief Financial Officer. Dr. William D. Schwieterman resigned as Mateon’s Chief Executive Officer but remains on Mateon’s Board of Directors, along with Dr. Trieu.

"I would like to welcome Mateon’s Dr. William D. Schwieterman and Matthew M. Loar to our team. They have been steadfast in their goal to maximize shareholder value. We structured the merger with the CVR to preserve the intrinsic value of the current Mateon’s pipeline for its prior shareholders, while allowing their participation in our pipeline and the growth potential of the new combined company," stated Vuong Trieu, Ph.D., Chairman and Chief Executive Officer. "Now that this merger is complete, we look forward to further value creation for our shareholder base as we advance the combined pipeline together, with the goal of having an approvable anti-cancer drug within a few years. I look forward to meeting our shareholders at various investor conferences including the upcoming BIO2019 in Philadelphia where we will present the combined pipeline."

The company’s lead product candidate, OT-101, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers, including high-grade gliomas and pancreatic cancer. The company plans to initiate phase 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer. During phase 2 clinical trials in pancreatic cancer, melanoma, and colorectal cancers (Study P001) and in high-grade gliomas (Study G004), meaningful clinical benefits were observed and OT-101 exhibited a favorable safety profile. These clinical benefits included long term survival and meaningful tumor reduction. Both partial and complete responses have been observed in the G004 Phase 2 clinical trial of OT-101 as a single agent in patients with aggressive brain tumors.

"The deep and sustained complete responses achieved in G004 with OT-101 alone as a single agent contributes to our optimism that new treatment strategies leveraging this promising anti-sense therapeutic candidate will favorably change the therapeutic landscape in these and other difficult-to-treat malignancies", said Fatih Uckun, MD, PhD, the Chief Medical Officer of Mateon. He added "The SIP platform displays a high clinical impact potential owing to its ability to robustly reactivate exhausted immune cells around the cancer tissue by a unique mechanism of action. We are committed to diligently advancing the OT-101 clinical trial program with the vision of bringing a new treatment option to cancer patients who are in urgent need for therapeutic innovations. I also look forward to rationally integrating Mateon’s assets into the SIP platform to develop additional innovative and effective cancer therapies that can be tailored to cancer patients’ special needs."

The company’s self-immunization protocol (SIP©) is based on novel and proprietary sequential treatment of cancers with OT-101 (an antisense against TGF-β2) and chemotherapies. This sequential treatment strategy is aimed at achieving effective self-immunization against a patients’ own cancer, resulting in robust therapeutic immune response and consequently better control of the cancer and improved survival. Prolonged states of being cancer-free have been observed in some patients with the most aggressive forms of cancer, raising a renewed hope for a potential cure. The use of OT-101 lifts the suppression of the patient’s immune cells around the cancer tissue, providing the foundation for an effective initial priming, which is critical for a successful immune response. The subsequent chemotherapy results in the release of neoantigens that result in a robust boost of the immune response. The company believes that a rational combination of the Oncotelic SIP platform with immune-modulatory drugs like interleukin 2 (IL-2) and/or immune checkpoint inhibitors has the potential to help achieve sustained and robust immune responses in patients with the most difficult-to-treat forms of cancer.

Following the merger, the company has approximately 83,120,000 shares of common stock and 193,713 shares of Series A Preferred Stock outstanding. Each share of Series A preferred stock will automatically convert into 1,000 shares of common stock following stockholder approval of additional authorized shares of common stock or a reverse split sufficient to permit conversion of all Series A preferred stock into common stock.

Exelixis’ Partner Takeda Announces Filing of New Drug Application in Japan for CABOMETYX® (Cabozantinib) for Advanced Renal Cell Carcinoma

On April 25, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of cabozantinib in Japan, has applied to the Japanese Ministry of Health, Labor and Welfare (MHLW) for approval to manufacture and sell CABOMETYX (cabozantinib) as a treatment for unresectable and metastatic renal cell carcinoma (RCC) in the country (Press release, Exelixis, APR 25, 2019, View Source [SID1234535395]). As a result of the submission, Exelixis will receive a $10 million milestone payment from Takeda, anticipated to be received in the second quarter of 2019.

Takeda’s application is based on the results of three clinical trials: METEOR, the Exelixis-sponsored phase 3 pivotal trial of cabozantinib versus everolimus in patients with advanced RCC that experienced disease progression following treatment with at least one prior VEGF receptor tyrosine kinase inhibitor (VEGFR-TKI); CABOSUN, the Alliance for Clinical Trials in Oncology-sponsored phase 2 trial comparing cabozantinib with sunitinib in patients with previously untreated advanced RCC with intermediate- or poor-risk disease; and Cabozantinib-2001, a Takeda-sponsored phase 2 trial in 35 Japanese patients with advanced RCC who had progressed after prior VEGFR-TKI therapy. Takeda’s phase 2 trial was the subject of a late-breaking abstract at the 107th Annual Meeting of the Japanese Urological Society on April 18, 2019.

"Takeda has proven to be a very effective partner in cabozantinib’s development program in Japan since the signing of our collaboration and licensing agreement in early 2017," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "This Japanese regulatory filing is an important milestone on the path toward offering CABOMETYX as a new therapeutic option for patients with unresectable, metastatic renal cell carcinoma in Japan. We congratulate our Takeda colleagues on the filing and look forward to further progress."

Per the terms of Exelixis and Takeda’s collaboration and license agreement, Exelixis received a $50 million upfront payment at the time of signing. Following the milestone associated with this regulatory filing, Exelixis will be eligible to receive from Takeda further development, regulatory and first-sale milestone payments of up to $80 million related both to previously treated and previously untreated RCC and previously treated hepatocellular carcinoma (HCC), as well as additional development, regulatory and first-sale milestones for potential future cabozantinib indications. Exelixis is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan.

Takeda fully funds cabozantinib development activities that are exclusively for the benefit of Japan and is responsible for 20% of the costs associated with global cabozantinib clinical trials, providing the company opts into those trials. As of today, Takeda has opted into and is co-funding CheckMate 9ER, the ongoing phase 3 pivotal trial of cabozantinib plus nivolumab versus sunitinib in previously untreated advanced RCC.

About RCC

The American Cancer Society’s 2019 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.1 Clear cell RCC is the most common type of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12 percent, with no identified cure for the disease.1 Approximately 32,000 patients in the U.S. and 70,000 globally require treatment, and an estimated 15,000 patients in the U.S. each year are in need of a first-line treatment for advanced kidney cancer.3

The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.4,5 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.6,7,8,9 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.5,6

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. 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 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 occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.
Perforations and Fistulas: GastrointestinaI (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula that cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.
Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.
Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.
Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.
Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.
Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 28 days prior to scheduled dental surgery or invasive dental procedures. Withhold CABOMETYX for development of ONJ until complete resolution.
Wound Complications: Wound complications were reported with CABOMETYX. Stop CABOMETYX at least 28 days prior to scheduled surgery. Resume CABOMETYX after surgery based on clinical judgment of adequate wound healing. Withhold CABOMETYX in patients with dehiscence or wound healing complications requiring medical intervention.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.
Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.
Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.
Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.
Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.