On September 8, 2021 AM-Pharma B.V., an emerging leader focused on developing therapeutics for severe medical conditions, and Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, reported that they have entered into an exclusive license agreement under which Kyowa Kirin gains the rights to develop and commercialize ilofotase alfa, AM-Pharma’s proprietary recombinant human alkaline phosphatase (Press release, Kyowa Kirin Pharmaceutical , SEP 8, 2021, View Source [SID1234587341]). Ilofotase alfa is currently being evaluated in the global pivotal REVIVAL Phase III clinical study as the potential first disease-altering treatment for sepsis-associated acute kidney injury (SA-AKI). In July of this year, AM-Pharma announced the enrollment of the first patient in Japan as part of the ongoing REVIVAL trial.

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"Kyowa Kirin is a leading Japanese specialty pharmaceutical company deeply rooted in science that shares our commitment to addressing high unmet medical needs. Based on the number of successful international partnerships they have, they are the ideal partner to support the commercialization of ilofotase alfa in Japan," stated Erik van den Berg, Chief Executive Officer at AM-Pharma. "This is a significant milestone for AM-Pharma as this agreement will optimize the commercialization of ilofotase alfa in the Japanese market and expedite our ability to bring our therapeutic candidate to a substantial patient population in Japan post-approval."

"As an organization centered around research, development and partnerships with innovative drug discovery organizations around the globe, we are excited to initiate this relationship with AM-Pharma to potentially improve the lives of patients and families affected by sepsis-associated acute kidney injury," added Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department at Kyowa Kirin. "Ilofotase alfa has demonstrated its therapeutic potential in AM-Pharma’s Phase II STOP-AKI study, and we look forward to being a strategic partner supporting the commercialization and thereby patient access of ilofotase alfa upon successful completion of the pivotal REVIVAL study."

Under the terms of the agreement, AM-Pharma will receive EUR 20 million upfront payment, and EUR 30 million related to milestones prior to regulatory submission, and up to EUR 195 million upon submission, NHI price listing and sales milestone payments bringing the overall deal value to EUR 245 million. In addition, AM-Pharma is entitled to tiered double-digit royalties on sales and a drug supply fee. Kyowa Kirin will gain the exclusive right to develop and commercialize ilofotase alfa in Japan. AM-Pharma is responsible for the completion of the REVIVAL pivotal Phase III study, as well as a Phase I pharmacokinetics, safety and tolerability study in Japan and drug supply, whereas Kyowa Kirin will be responsible for the regulatory approval process and commercialization of ilofotase alfa in Japan.

About REVIVAL

The REVIVAL trial is a Phase III pivotal study evaluating AM-Pharma’s proprietary recombinant alkaline phosphatase, ilofotase alfa, for the treatment of patients with SA-AKI. The primary endpoint of the study is all-cause mortality 28 days post-treatment start with ilofotase alfa at a dose of 1.6 mg/kg. In the Phase II study of ilofotase alfa, the patient group treated with this dose experienced a statistically significant 46% relative reduction in mortality compared to the group treated with placebo (p= 0.022). REVIVAL was initiated in November 2020 and is enrolling up to 1,600 patients in North America, Europe and Japan. As per the study protocol, four interim analyses for futility and/or efficacy will be conducted when enrollment hits certain levels and the first futility analysis will occur when 400 patients have been treated.

Up to about 120 clinical sites worldwide, including as many as 11 sites in Japan, will enroll patients into the single global pivotal Phase III REVIVAL trial in SA-AKI patients. The U.S. Food and Drug Administration, European Medicines Agency and Japanese Pharmaceuticals and Medical Devices Agency have all approved the REVIVAL protocol.

In addition to the REVIVAL study, the PMDA has approved enrollment into a Phase I pharmacokinetics (PK), safety and tolerability study in healthy Japanese subjects, which is being conducted in parallel to REVIVAL in Japan.

About ilofotase alfa

AM-Pharma’s therapeutic candidate is a proprietary recombinant human Alkaline Phosphatase (AP) constructed from two naturally occurring human isoforms of the AP enzyme. The Company’s compound is highly stable and active and has a dual mechanism of action. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as, ATP, ADP, lipopolysaccharide (LPS) and other extracellular substrates that drive acute inflammation, coagulation and microvascular ischemia. Research has shown that ATP dephosphorylation has a double effect in protecting against kidney injury. When the pro-inflammatory ATP is dephosphorylated, the resulting adenosine further reduces inflammation through the activation of the immunosuppressive adenosine A2a receptor pathway (A2aR). AM-Pharma has shown that treatment of patients with ilofotase alfa not only reduces local and systemic inflammation but also protects the kidney, and possibly other organs, against further damage.

About AKI and Sepsis

Acute Kidney Injury (AKI) involves inflammatory processes in the kidney which can lead to complete loss of renal function. Hospital‐acquired AKI affects annually around 3 million patients in the US, Europe, and Japan, and is associated with mortality in roughly 700,000 patients. It occurs in 40-60% of critical care admissions. Depending on the severity and cause of renal injury, mortality occurs in up to 60% of the cases. In the US alone, hospitals spend around $10 billion each year on managing this major medical problem.1,2,3

Sepsis is a condition that is responsible for 1 out of 3 deaths in hospitals and is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. The kidney is the most commonly affected organ, resulting in SA-AKI and significantly increasing the risk for mortality and morbidity in sepsis. No singular effective therapy to alter the progression of these devastating conditions has been approved.4

On September 8, 2021 XBiotech Inc. (NASDAQ: XBIT) ("XBiotech") reported that Benjamin Musher M.D., will chair XBiotech’s clinical program for pancreatic cancer (Press release, XBiotech, SEP 8, 2021, View Source [SID1234587376]). The Company is developing a novel cancer drug, Natrunix, to be used in combination with cytotoxic anti-cancer agents. Natrunix specifically blocks a substance that has been shown to stimulate tumor blood supply and break down connective tissue, which can support tumor growth and destruction of healthy tissue. The anti-inflammatory activity of Natrunix is also being evaluated for its ability to reduce the toxicity and injury caused by the cytotoxic anti-cancer agents themselves.

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XBiotech’s pancreatic cancer program, 1-BETTER, launched with a randomized, double-blind, placebo-controlled Phase 1-2 study, allows the Company to evaluate dose levels, drug interaction and anti-cancer activity for Natrunix. Dr. Musher is Medical Director of Medical Oncology at Dan L. Duncan Comprehensive Cancer Center and Associate Professor at Baylor College of Medicine. Dr. Musher is a member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and has authored numerous peer-reviewed articles in oncology, including treatments for pancreatic cancer. In addition to Natrunix, Dr. Musher has investigated cutting-edge pancreatic cancer therapies, including the use of tumor-targeting viruses. He has also researched and published on clinical practices relating to the treatment of pancreatic cancer, to better understand the decision-making processes and challenges faced by oncologists in the treatment of this extremely challenging form of cancer.

As chair of the 1-BETTER pancreatic cancer program, Dr. Musher will lead the clinical program and personally treat pancreatic cancer patients at the Dan L. Duncan Comprehensive Cancer Center, at St. Luke’s Hospital in Houston, Texas. Dr. Musher stated, "Pancreatic cancer is a devastating disease and remains the third leading cause of cancer-related death in the United States. Most patients with metastatic pancreatic cancer are eligible for only cytotoxic chemotherapy, which generally yields short-lived responses and can cause significant toxicity. More effective and rationally designed therapies are therefore desperately needed. By targeting cancer-related inflammation, Natrunix may facilitate better control of tumor growth, reduce toxicity from chemotherapy, and improve well-being of patients with advanced pancreatic cancer."

Dr. Musher will oversee the 1-BETTER study that will involve at least 20 other leading cancer centers around the country. The study will evaluate Natrunix in combination with ONIVYDE and 5-fluorouracil and generate preliminary data on overall survival, progression-free survival, time-to-treatment failure, and objective response rates. Numerous quality-of-life measures will also be explored, hopefully showing a reduction in chemotherapy-related toxicity.

John Simard, President and CEO of XBiotech commented, "We are honored to have Dr. Musher chair this study for which we are eagerly anticipating results."

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On September 8, 2021 Amgen (NASDAQ: AMGN) reported results from two analyses of the Phase 2 CodeBreaK 100 clinical trial evaluating LUMAKRAS (sotorasib), the first and only KRASG12C inhibitor approved in the U.S., in the treatment of previously treated patients with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) (Press release, Amgen, SEP 8, 2021, View Source [SID1234587394]). These new analyses, respectively, provide encouraging evidence of durable systemic anticancer activity in patients with previously treated, stable brain metastases with LUMAKRAS, as well as insights into biomarkers of LUMAKRAS response. Together with a poster describing a recently initiated clinical study of the investigational half-life extended (HLE) bispecific T cell engager (BiTE) molecule acapatamab (formerly AMG 160) in patients with NSCLC, these data are being featured during the virtual 2021 World Conference on Lung Cancer (WCLC21) hosted by the International Association for the Study of Lung Cancer (IASLC).

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"Amgen is expanding the reach, impact and potential of our innovative therapies to personalize care for patients with historically difficult-to-treat cancers like lung cancer," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are pleased to present additional analyses for LUMAKRAS, our newly approved KRASG12C inhibitor, as well as a trial-in-progress poster for acapatamab, our investigational BiTE molecule being studied in NSCLC and other solid tumors. Of the data presented at WCLC, we are particularly encouraged by the first evaluation of LUMAKRAS’ ability to maintain stabilization of brain metastases in patients with previously treated, stable brain metastases. We look forward to the results from our CodeBreaK 101 study where we are studying a cohort of KRAS G12C-mutated NSCLC patients with untreated, active brain metastases to better understand the clinical benefit of LUMAKRAS."

New Analyses From the LUMAKRAS Phase 2 CodeBreaK 100 Clinical Trial
In a post-hoc analysis (WCLC21 Poster 52.03) of 40 patients (23% of 174 trial participants) with KRAS G12C-mutated advanced NSCLC who had stable, previously treated brain metastases at their enrollment in the CodeBreaK 100 trial, LUMAKRAS achieved a 77.5% disease control rate (DCR), a median progression-free survival (PFS) of 5.3 months and a median overall survival (OS) of 8.3 months. This DCR was similar to patients without brain metastases. In patients evaluable by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria, 14 of 16 patients (88%) maintained intracranial disease control of their stable brain lesions during LUMAKRAS therapy with two achieving complete responses of non-target lesions. The safety profile of LUMAKRAS in the brain metastases group was consistent with previous reports. Amgen is enrolling patients with active brain metastases in an arm of the CodeBreaK 101 study (NCT04185883).

"Up to 40% of patients with KRAS G12C-mutated NSCLC may develop brain metastases.1 Given the overall poor prognosis for this patient subset, there is an urgent need for novel treatment options,"2 said lead author Suresh S. Ramalingam, M.D., executive director of Winship Cancer Institute of Emory University in Atlanta. "Our results demonstrate the potential of sotorasib to provide meaningful clinical benefit for KRAS G12C-mutated NSCLC in the brain."

An additional exploratory descriptive analysis of CodeBreaK 100 being presented during a Mini Oral Presentation (MA14.03) examined whether the mutation profile of the tumors, in addition to KRASG12C, is correlated with patients’ responses or resistance to LUMAKRAS. An analysis of baseline tumor samples from 65 patients revealed no single genetic signature that predicted LUMAKRAS responses and ongoing evaluations will be needed to further identify potential targetable mechanisms of resistance. However, the KEAP1 mutation, a known driver of poor clinical outcomes, was observed in 7 of 22 patients with early progression and PFS of less than 3 months.

"The introduction of sotorasib ushered in a new standard of care for patients with KRAS G12C-mutated NSCLC," said lead author Ferdinandos Skoulidis, M.D., Ph.D., assistant professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "These biomarker data provide direction for continued research into characterizing mutation profiles associated with sotorasib treatment response to help guide clinical practice and inform innovative combination approaches to overcome potential mechanisms of resistance."

Advancing BiTE Molecule Acapatamab in NSCLC
In addition to the LUMAKRAS data, a trial-in-progress abstract outlined the design of an ongoing open-label, Phase 1b study (NCT04822298) evaluating the safety and tolerability of acapatamab, a half-life extended BiTE immuno-oncology therapy that targets prostate specific membrane antigen (PSMA)-expressing cancer cells in adults with relapsed/refractory NSCLC. The encouraging benefit-risk profile of acapatamab in an ongoing trial of patients with metastatic castration-resistant prostate cancer (mCRPC) (NCT03792841) suggested its potential for patients with NSCLC, as up to 49 to 85% of the endothelial cells in a tumor’s newly grown blood supply express PSMA.3,4 Acapatamab engages PSMA on cancer cells and CD3 on T cells, inducing T-cell activation, proliferation and target cell lysis to prompt a cancer-fighting immune response.5

About LUMAKRASTM (sotorasib)
Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRASG12C inhibitor.6 LUMAKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.7

In May 2021, LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S., under accelerated approval. LUMAKRAS is also approved in the United Arab Emirates.

Amgen is progressing the largest and broadest global KRASG12C development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, including triplets, with clinical trial sites spanning five continents. To date, LUMAKRAS has treated almost 3,000 patients around the world through the clinical development program and commercial use.

In the U.S., LUMAKRAS was reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen is participating in the FDA’s Project Orbis initiative and through the initiative, has submitted Marketing Authorization Applications (MAAs) for sotorasib in Australia, Brazil, Canada and the United Kingdom. Additionally, Amgen has submitted an MAA in the EU and New Drug Applications in Japan (J-NDA), Switzerland, South Korea, Singapore, Israel, Turkey and Taiwan.

LUMAKRAS is also being studied in multiple other solid tumors.6

LUMAKRASTM (sotorasib) U.S. Indication
LUMAKRASTM is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

LUMAKRAS (sotorasib) Important Safety Information

Hepatotoxicity

LUMAKRAS can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
Among 357 patients who received LUMAKRAS in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
Monitor liver function tests (ALT, AST and total bilirubin) prior to the start of LUMAKRAS, every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations.
Withhold, dose reduce or permanently discontinue LUMAKRAS based on severity of adverse reaction.
Interstitial Lung Disease (ILD)/Pneumonitis

LUMAKRAS can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS in CodeBreaK 100, ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS was discontinued due to ILD/pneumonitis in 0.6% of patients.
Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS if no other potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions

The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough.
Drug Interactions

Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS.
If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS 4 hours before or 10 hours after a locally acting antacid.
Please see LUMAKRASTM full Prescribing Information.

About Non-Small Cell Lung Cancer and the KRAS G12C Mutation
Lung cancer is the leading cause of cancer-related deaths worldwide, and it accounts for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined.8 Overall survival rates for NSCLC are improving but remain poor for patients with advanced disease and 5-year survival is only 7% for those with metastatic disease.9

KRAS G12C is the most common KRAS mutation in NSCLC.10 In the U.S., about 13% of patients with non-squamous NSCLC harbor the KRAS G12C mutation.11 Unmet medical need remains high and treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working. The outcomes with current therapies are suboptimal with a median progression-free survival of approximately 4 months following second-line treatment of KRAS G12C-mutated NSCLC.12

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 800 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been submitted for publication.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201).

For information, please visit www.hcp.codebreaktrials.com.

About BiTE Technology
BiTE (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage a patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing BiTE molecules across a broad range of hematologic malignancies and solid tumors and further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

About Acapatamab (formerly AMG 160)
Acapatamab is a half-life extended (HLE) BiTE immune-oncology therapy that targets PSMA-expressing cancer cells being investigated in prostate cancer and non-small cell lung cancer (NSCLC).

Simultaneously binding to PSMA on tumor cells and CD3 on T cells, acapatamab is designed to engage patients’ own T cells to fight cancer. In an ongoing Phase I, first-in-human study in patients with metastatic castration-resistant prostate cancer (mCRPC), acapatamab has demonstrated a manageable safety profile and promising efficacy as monotherapy.3

The mCRPC study is also examining acapatamab in combination with pembrolizumab. A Phase 1/2, master protocol study is investigating the safety, tolerability, dosing and efficacy of acapatamab, in combination with enzalutamide, abiraterone, or the PD-1 inhibitor AMG 404 in patients with earlier-line mCRPC. An ongoing open-label, Phase 1b study is evaluating the safety and tolerability of acapatamab in adults with relapsed/refractory NSCLC.

On September 8, 2021 – Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that Dr. Amit Kumar, Anixa’s Chief Executive Officer, will present at the virtual H.C. Wainwright 23rd Annual Global Investment Conference being held September 13-15, 2021 (Press release, Anixa Biosciences, SEP 8, 2021, https://ir.anixa.com/news/detail/983/anixa-biosciences-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference [SID1234587412]).

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During the presentation, Dr. Kumar will provide an overview of Anixa’s business and highlight recent corporate achievements, including the recent FDA clearance to proceed with clinical trials of its CAR-T based ovarian cancer therapeutic program, as well as anticipated milestones in its breast cancer vaccine clinical trials. Company management will also be available to participate in online one-on-one meetings with conference attendees.

Details of Anixa’s presentation are as follows:

Event: H.C. Wainwright 23rd Annual Global Investment Conference

Date & Time: On demand, beginning 7:00 a.m. ET, Monday, September 13, 2021

Webcast link: View Source

An archive of the webcast will remain available for 90 days after the event.

On September 8, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on Axumin (fluciclovine F 18) at the upcoming 2021 AUA Annual Meeting (AUA2021), to be held in a virtual format from September 10 to 13, 2021 (Press release, Blue Earth Diagnostics, SEP 8, 2021, View Source [SID1234587431]). Details of selected moderated poster presentations are listed below.

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NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

Blue Earth Diagnostics invites participants at AUA2021 to attend the presentations above and to learn more about the Company in the AUA2021 Virtual Science & Technology Hall. For full session details and scientific presentation listings, please see the AUA online program here.

Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.