On June 15, 2020 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that the full top-line results from the pivotal phase 2 HORIZON study, evaluating intravenous melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma (RRMM), have been presented at the ongoing 25th European Hematology Association (EHA) (Free EHA Whitepaper) meeting, EHA (Free EHA Whitepaper) (Press release, Oncopeptides, JUN 15, 2020, View Source [SID1234561118]). The results support the NDA submission to the US Food and Drug Administration, FDA, for accelerated approval of melflufen. The Company is on track to submit the application to FDA by the end of Q2, 2020.

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Oncopeptides will host a webcast on Tuesday, June 16 at 10.00 (CET) to provide comments on the full top-line results. The webcast can be followed via the link: View Source

All data were confirmed by the Independent Review Committee (IRC), with only minimal discordance.

Melflufen is a first-in-class anticancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. The results from the HORIZON study demonstrates that melflufen in combination with dexamethasone, have the potential to provide a therapeutic option for patients with relapsed refractory multiple myeloma (RRMM) that are hard to treat and have a poor prognosis, including patients with triple class refractory myeloma and patients with Extramedullary Disease. Responses were durable and often deepened with prolonged treatment, suggesting that patients could benefit from staying on treatment for as long as possible. The results are consistent with previously reported data, while no new safety concerns were identified. The full poster presentation is available on Oncopeptides’ website: View Source

"The HORIZON data is an important milestone for Oncopeptides and further validates our Peptide-Drug Conjugate platform", says Klaas Bakker, MD and CMO of Oncopeptides. "The results are in line with results from previous interim analyses. Notably, the PFS of 8.5 months in responding patients (both all treated and triple-class refractory), was materially higher than the DOR, which is explained by the relatively long-time it took for patients to respond (median 1.9 months). This is very encouraging for patients with an unmet need; ultimately this is the period patients benefit from treatment with melflufen. The fact that the treatment also seems to be well tolerable makes this a potentially attractive treatment option for a fast-growing patient population with a significant unmet medical need".

This information was submitted for publication at 08:00 (CET), June 15, 2020.

About the HORIZON (OP-106) study

In the pivotal phase 2 HORIZON study 157 multiple myeloma patients have been enrolled and evaluated. The study was fully recruited in October 2019 and the final data cut was made on January 14th. The patients in the study are refractory to pomalidomide and/or daratumumab after failing on immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). The HORIZON study population includes subgroups of patients who were triple-class refractory and/or had EMD and/or had cytogenetic high-risk features.

About melflufen

Melflufen (INN melphalan flufenamide) is a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

On June 15, 2020 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, reported that it has appointed Dr. Hasan Jafri as Chief Medical Officer (CMO) (Press release, Aridis Pharmaceuticals, JUN 15, 2020, View Source [SID1234561117]). Dr. Jafri replaces Dr. Paul Mendelman who has been serving as the Company’s interim CMO since October, 2019 and will transition to the role of senior medical advisor to the Company.

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"It is a pleasure to welcome Dr. Jafri to the Aridis team as he brings extensive clinical, research and industry experience across the full spectrum of the infectious disease treatment landscape, especially in anti-infective immunotherapies," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "I also wish to extend gratitude to Dr. Mendelman for his tremendous contribution in helping maintain the development pace of our clinical programs and implementation of the Company’s APEX technology platform used in the discovery of COVID-19 mAbs and other antibodies against lung disease pathogens."

Dr. Jafri comes to Aridis from AstraZeneca, where he most recently served as Senior Medical Director, Clinical Research and Development, Microbial Sciences, Clinical Head of Antibacterial mAb Program, and Coordinator of the European Public-Private COMBACTE-NET & COMBACTE-MAGNET consortia focused on antibacterial drug development supported by the Innovative Medicines Initiative (IMI). During his tenure at AstraZeneca, he led the clinical development of the anti-bacterial monoclonal antibodies within the Serious Bacterial Infections Franchise, including its Phase 2 programs MEDI4893 (anti-S. aureus alphatoxin mAb) and MEDI3902 (anti-P. aeruginosa Psl/PcrV mAb). He also served as the AstraZeneca representative on the Infection Control Strategic Governance Group (SGG), an industry committee tasked with advising the European Commission and IMI on R&D priorities. In addition to the antibacterial programs, Dr. Jafri has been a leader in respiratory syncytial virus (RSV) R&D. Dr. Jafri has over 25 years of experience in clinical practice and research, especially in the area of serious healthcare associated and community acquired infections, respiratory viral infections and invasive fungal infections (in immunocompromised and immunocompetent hosts), and biomarker and translational research. He has been involved in the design and conduct of multiple Phase 1–4 clinical studies to assess novel small and large molecules against bacterial, viral and fungal pathogens. Prior to joining AstraZeneca, Dr. Jafri served as a Professor in the Department of Pediatric Infectious Diseases and the Department of Clinical Science Research at the University of Texas Southwestern Medical Center at Dallas. He was the Chief of Division of Clinical Pharmacology, Director of the Pediatric Infectious Diseases fellowship program, and Director of the NICHD Pediatric Pharmacology Research Center. Dr. Jafri has authored over 70 peer reviewed journal articles and presented over 100 original research abstracts at National and International Conferences.

"I’m excited to join Aridis especially at such a critical time within the infectious disease arena given the COVID-19 pandemic, the global antibiotic resistance challenges and the need for new innovative antibacterial therapies. I look forward to playing an integral role in advancing our pipeline of differentiated anti-infective treatments for multiple indications and bringing these novel and potentially lifesaving medicines to patients," commented Dr. Hasan Jafri, Chief Medical Officer of Aridis Pharmaceuticals. "I’m particularly passionate about antiviral and antibacterial immunotherapy using monoclonal antibodies after having spent the past decade working on this area at AstraZeneca/MedImmune and have helped advance multiple programs through global Phase 3 clinical studies."

On June 15, 2020 Medison Pharma Trading AG, a fully owned subsidiary of Medison Pharma Ltd., and Alpha Tau Medical Ltd., the developer of a breakthrough alpha-radiation cancer therapy "Alpha DaRT," reported an exploratory collaboration in the oncology field in Central and Eastern Europe (Press release, Medison Pharma, JUN 15, 2020, View Source [SID1234561116]). Medison is a specialized pharmaceutical and biotech company focused on licensing highly innovative, cutting edge therapeutics for patients in need of life-saving therapies in various international markets. According to the new arrangement, Medison will take advantage of its deep familiarity and extensive local infrastructure in CEE in order to evaluate the market opportunity towards the launch of the cutting-edge technology in the region.

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Meir Jakobsohn, CEO of Medison Pharma, commented: "After licensing Alpha DaRT for the Canadian and Israeli markets, the collaboration with Alpha Tau for the Central and Eastern European region is a natural development that demonstrates our commitment to save and improve lives of patients in need in the CEE region. We continue to seek opportunities that will deliver innovative and valuable solutions in all the regions in which we operate."

On June 15, 2020 Thermo Fisher Scientific reported that The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881) (Press release, Thermo Fisher Scientific, JUN 15, 2020, View Source [SID1234561115]). The assay, first introduced to the market as a research product in November 2019, is designed to run on the new Ion Torrent Genexus System, the first fully automated next-generation sequencing (NGS) platform with a specimen-to-report workflow that delivers comprehensive genomic profiling results in a single day.

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Thermo Fisher recently announced it had expanded its strategic partnership agreement with Agios Pharmaceuticals to co-develop the companion diagnostic (CDx) for vorasidenib, an investigational, oral, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 enzymes currently under evaluation in the Phase 3 INDIGO study for IDH mutant LGG. Over time, Thermo Fisher seeks to receive premarket approval (PMA) for the Oncomine Precision Assay as a companion diagnostic for multiple therapies, as well as approval for liquid biopsy tumor profiling in lung cancer and solid tissue tumor profiling in multiple cancer types.

"Access to timely, comprehensive genomic profiling data that supports well-informed treatment decisions can be challenging under the current cancer-testing paradigm," said Dr. Alain Mita, Associate Professor of Medicine, Co-Director of the Experimental Therapeutics Program at Cedars-Sinai Medical Center. "The possibility of having multi-biomarker profiling that is generated onsite and available in about a day is game-changing for the manner and speed in which oncologists are able to determine and prescribe the most appropriate treatment for their patients."

The goal of the FDA’s Breakthrough Device Program is to provide patients and health care providers with timely access to medical devices by speeding up their assessment and review, while preserving the agency’s statutory standards. Once cleared under PMA, the Oncomine Precision Assay will maximize detection of guideline-recommended biomarkers, such as EGFR, ALK, KRAS, BRAF, ROS1, NTRK, RET, HER2 and others.

When combined with the Genexus System, molecular testing laboratories can generate comprehensive NGS results within the same timeframe as single-gene tests. Additionally, these features set the stage for molecular pathologists in the future to analyze NGS information in parallel with first-line testing modalities, such as immunohistochemistry (IHC).

"Breakthrough designation for the companion diagnostic is a big step forward in our endeavor to ensure that more clinicians can have quicker access to comprehensive genomic information," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Receiving this insight at the speed that the Genexus System enables can help expedite patient therapy selection, which is a critical need in the clinic today."

With its unprecedented speed to results, the Genexus System is positioned to accelerate a broad range of application areas, including oncology, infectious disease, inherited disease and reproductive health, among others. Since its launch in November 2019 as a research only solution, the integrated sequencer has also been enabled to analyze SARS-CoV-2 samples to support epidemiology or contact tracing studies.

On June 15, 2020 Sanofi reported that preclinical data for investigational compounds in breast, lung, multiple myeloma and other cancers will be featured at the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II on June 22-24 (Press release, Sanofi, JUN 15, 2020, View Source [SID1234561114]). The results that will be presented underscore the Company’s commitment to transforming scientific knowledge and advances in innovative oncology therapies.

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"We believe the innovation and efforts we are driving in oncology have the potential to make a significant difference in the lives of people living with cancer," said Yong Jun Liu, Global Head of Research, Senior Vice President R&D at Sanofi. "Preclinical data presented at this year’s AACR (Free AACR Whitepaper) Virtual Meeting II showcase the depth of our pipeline and support the continued exploration of our investigational assets that reflect some of the most cutting-edge scientific technologies and platforms in oncology."

Preclinical data show anti-tumor activity and support further research across a range of solid tumors, including evolving evidence in breast and lung cancers

Sanofi continues to embrace a variety of technological approaches to address some of the hardest-to-treat forms of cancer, including breast and lung cancer.

Abstract 3452: Pre-clinical development of next generation Selective Estrogen Receptor Degrader – SAR439859 (Dr. Fangxian Sun, Sr.; Tuesday, June 23: Virtual Minisymposium Session, 10:20-10:30 AM)

SAR439859 (SERD ‘859) is a oral endocrine backbone therapy in hormone receptor positive (HR+) breast cancer that selectively binds to estrogen receptors in breast cancer cells to block signaling and trigger their degradation. Breast cancer is the second most common form of cancer worldwide, with an estimated 70-80% of breast cancers being HR+.

Preclinical research from SERD ‘859 demonstrated anti-tumor activity in HR+ breast cancer cell lines.
SERD ‘859 showed significant anti-tumor activity against endocrine-therapy-resistant, patient-derived tumor models that correlated with pharmacokinetic (PK) exposure and pharmacodynamic (PD) modulation in target tissue.
Looking to potential combination therapies, researchers observed strong synergistic activity between SERD ‘859 and palbociclib, a CDK4/6 inhibitor
Abstract 561/16: Pre-clinical efficacy data for the anti-CEACAM5-DM4 ADC SAR408701 supports further development in lung and gastro-intestinal cancers (Dr. Stephanie Decary; Monday, June 22: Poster Display, 9:00 AM-6:00 PM)

SAR408701 (SAR ‘701) is Sanofi’s potential first-in-class antibody-drug conjugate targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-squamous non-small cell lung cancers (NSCLC). Approximately 20-30% of lung cancers have a high expression of CEACAM5.

Results from patient-derived xenograft mouse studies of SAR ‘701 in non-small cell lung cancer will be presented.
Findings revealed a potential correlation between preclinical activity of the compound and the expression of CEACAM5 in lung tumors.
Further exploration of SAR ‘701 clinical activity is also ongoing across a number of CEACAM5-expressing solid tumors.
Abstract 1943/10: SHP2 inhibition as the backbone of targeted therapy combinations for the treatment of cancers driven by oncogenic mutations in the RAS pathway (Dr. Jacqueline Smith; Monday, June 22: Poster Display, 9:00AM-6:00PM)

SAR442720 (RMC-4630) is an investigational inhibitor of the cellular enzyme SHP2 developed jointly by Sanofi and Revolution Medicines. Inhibitors of SHP2 are designed to reduce cell growth signaling in the RAS-MAP kinase pathway that is frequently overactive in human cancers, like NSCLC.

Results from preclinical combination studies showed SAR442720 enhanced the anti-tumor activity of EGFR-mutant or KRASG12C inhibitors.
Preclinical data add to growing body of evidence supporting Sarclisa (isatuximab-irfc) in multiple myeloma and other blood cancers

Sanofi is committed to investigating new treatments for patients with multiple myeloma, a difficult-to-treat blood cancer, who often need multiple lines of therapy. Despite available treatments, multiple myeloma remains an incurable malignancy and is associated with significant patient burden.

Abstract 5179/5: Isatuximab based combinations induce potent tumor growth inhibition in pre-clinical models of multiple myeloma and acute lymphocytic leukemia (Dr. Chen Zhu; Monday, June 22: Poster Display, 9:00 AM-6:00 PM)

Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. It is currently approved for use in the U.S. and EU in combination with pomalidomide and dexamethasone for the treatment of certain adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Results from a study using patient-derived mouse xenograft models showed anti-tumor activity with Sarclisa in combination with standard-of-care treatments in both multiple myeloma (pomalidomide, lenalidomide, bortezomid, carfilzomib, melphalan) and acute lymphocytic leukemia (vincristine, cytarabine, cyclophosphamide). These potential uses of Sarclisa are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
Early science: new approaches in blood cancer research

Abstract 2266/1: SAR442085, a next generation anti-CD38 antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) against multiple myeloma (Dr. Angela Virone-Oddos; Monday, June 22: Poster Display, 9:00 AM-6:00 PM)

Current anti-CD38 treatments in combination with standard treatments represent a major advancement in the treatment of patients with relapsed and refractory multiple myeloma, but unmet needs remain. Sanofi scientists investigating a next-generation anti-CD38 antibody SAR442085 for the treatment of multiple myeloma will present preclinical data at the meeting.

Findings from a study of SAR442085 include antibody-dependent cellular cytotoxicity activity in vivo compared to currently available anti-CD38 antibodies.
SAR442085 demonstrated a higher level of natural killer (NK) cell activation against primary plasma cells in patient samples and potent in vivo single-agent activity against tumor cells expressing human CD38 in a C57BL/6 mouse model.
SAR442085 is currently being evaluated in Phase I clinical trials in patients with relapsed/refractory multiple myeloma.
Abstract 5641/2: CD28 expression on multiple myeloma cells enhances the cytotoxic activity of CD38/CD28xCD3 trispecific T-cell engager (Dr. Nizar El-Murr; Monday, June 22: Poster Display, 9:00 AM-6:00 PM)

Sanofi scientists are also investigating the trispecific T-cell engager SAR442257 (CD38/CD28xCD3) as a potential treatment for multiple myeloma.

Preclinical data show that SAR442257 is active on CD38 in multiple myeloma models.
SAR442257 can also directly target CD28, a T-cell activating protein expressed on tumor cells, enhancing the protein’s anti-tumor activity and allowing it to bind to tumor cells when CD38 is occupied by other antibodies.
The clinical significance of the preclinical findings relating to SERD ‘859, SAR ‘701, SAR442720, Sarclisa, SAR442085 and SAR442257 described above are currently under investigation.

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Sarclisa is approved in the EU, U.S., Switzerland, Canada and Australia in combination with pom-dex for the treatment of certain adults with relapsed refractory MM. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been evaluated by any regulatory authority.

For more information on Sarclisa clinical trials please visit www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is SARCLISA?

SARCLISA is a prescription medicine used in combination with pomalidomide and dexamethasone to treat adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma.

It is not known if SARCLISA is safe and effective in children.

Do not receive SARCLISA if you have a history of severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in full Prescribing Information).

Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. SARCLISA may harm your unborn baby. You should not receive SARCLISA during pregnancy.
Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after your last dose of SARCLISA. Talk to your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA.

are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not breastfeed during treatment with SARCLISA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive SARCLISA?

SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
SARCLISA is given in treatment cycles of 28 days (4 weeks), together with the medicines pomalidomide and dexamethasone.
In cycle 1, SARCLISA is usually given weekly.
Starting in cycle 2, SARCLISA is usually given every 2 weeks.
Your healthcare provider will decide how long you should receive SARCLISA.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Your healthcare provider will give you medicines before each dose of SARCLISA to help reduce the risk of infusion reactions (make them less frequent and severe).
What are the possible side effects of SARCLISA?

SARCLISA may cause serious side effects, including:

Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe.
Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each dose of SARCLISA.
Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA, if you have an infusion reaction.
Tell your healthcare provider right away if you develop any of the following symptoms of infusion reaction during or within 24 hours after an infusion of SARCLISA:

feeling short of breath
cough
chills
nausea
Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and certain white blood cells can be severely decreased. You may have an increased risk of getting certain infections, such as upper and lower respiratory infections.
Your healthcare provider will check your blood cell counts during treatment with SARCLISA. Your healthcare provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with SARCLISA.

Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA.

Risk of new cancers. New cancers have happened in people during treatment with SARCLISA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA.
Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA. Tell all of your healthcare providers that you are being treated with SARCLISA before receiving blood transfusions.
The most common side effects of SARCLISA include:

-lung infection (pneumonia)

-upper respiratory tract infection

-decreased red blood cell counts

(anemia)

-diarrhea

-decreased platelet counts (thrombocytopenia)

These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist.