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Amgen (NASDAQ:AMGN) as we speak introduced the U.S. Meals and Drug Administration (FDA) has accepted BLINCYTO ® (blinatumomab) for the remedy of grownup and pediatric sufferers one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) within the consolidation section, no matter measurable residual illness (MRD) standing.

“B-ALL is an aggressive blood most cancers with enduring excessive unmet want. BLINCYTO has helped hundreds of sufferers with B-ALL over the past 10 years. At present’s approval within the frontline consolidation section, no matter MRD standing, permits us to achieve extra sufferers than ever with this transformative, first-in-class Bispecific T-cell Engager (BiTE ^® ) remedy,” mentioned Jay Bradner , M.D., government vice chairman, Analysis and Growth, and chief scientific officer at Amgen.

The approval marks the third indication for BLINCYTO and is predicated totally on the Part 3 E1910 scientific trial led by ECOG-ACRIN Most cancers Analysis Group that studied sufferers with newly recognized Philadelphia chromosome-negative B-ALL receiving postinduction consolidation remedy, which goals to deepen remission to realize sturdy responses. Examine outcomes demonstrated that BLINCYTO added to multiphase consolidation chemotherapy confirmed superior general survival (OS) versus chemotherapy alone. The three-year OS was 84.8% within the BLINCYTO plus chemotherapy arm (n=112) and 69% within the chemotherapy arm (n=112), with the hazard ratio for OS of 0.42. With a median follow-up of 4.5 years, the 5-year OS was 82.4% within the BLINCYTO plus chemotherapy arm and 62.5% within the chemotherapy arm.

“Within the E1910 examine, blinatumomab lowered threat of loss of life and confirmed a outstanding enchancment in general survival,” mentioned Selina M. Luger , M.D., professor of hematology-oncology on the College of Pennsylvania’s Perelman College of Medication and Abramson Most cancers Middle, chair of the ECOG-ACRIN Leukemia Committee and an investigator on the examine. “This approval redefines the usual of take care of sufferers with B-ALL and supplies them with a more practical remedy choice than normal chemotherapy alone.”

“The chance of B-ALL recurrence after the preliminary section of remedy is comparatively excessive, making this approval for sufferers noteworthy,” mentioned E. Anders Kolb , M.D., president and chief government officer of The Leukemia & Lymphoma Society. “B-ALL is the most typical sort of ALL and having one other efficient choice accessible earlier in a affected person’s remedy journey is important for clinicians who’re working to provide these sufferers extra time with their family members.”

The E1910 examine was designed and performed independently from business. ECOG-ACRIN sponsored the trial with public funding from the Nationwide Most cancers Institute (NCI), a part of the Nationwide Institutes of Well being (NIH). Different NCI-funded community teams took half within the examine. As well as, Amgen supplied BLINCYTO and assist by way of an NCI Cooperative Analysis and Growth Settlement.

About Acute Lymphoblastic Leukemia (ALL)
ALL, also called acute lymphoblastic leukemia, is a fast-growing sort of blood most cancers that develops within the bone marrow and may generally unfold to different components of the physique, together with the lymph nodes, liver, spleen, and central nervous system. ALL is a uncommon illness, with 6,540 new circumstances recognized within the U.S. in 2023 affecting each kids and adults. ¹ B-ALL begins in immature cells that will usually become B-cell lymphocytes, that are white blood cells that develop in bone marrow. ^2,3 B-ALL is the most typical sort of ALL, constituting roughly 75% of circumstances in adults. ⁴

About BLINCYTO ^® (blinatumomab)
BLINCYTO is the primary globally accepted BiTE ^® immuno-oncology remedy that targets CD19 floor antigens on B cells. BiTE ^® molecules combat most cancers by serving to the physique’s immune system detect and goal malignant cells by participating T cells (a kind of white blood cell able to killing different cells perceived as threats) to most cancers cells. By bringing T cells close to most cancers cells, the T cells can inject toxins and set off most cancers cell loss of life (apoptosis). BiTE ^® immuno-oncology therapies are presently being investigated for his or her potential to deal with all kinds of cancers.

BLINCYTO was granted breakthrough remedy and Precedence Evaluation designations by the U.S. FDA and is accepted within the U.S. for the remedy of:

• Grownup and pediatric sufferers one month or older with CD19-positive Philadelphia chromosome-negative B-ALL in the course of the consolidation section of multiphase remedy.
• CD19-positive B-ALL in first or second full remission with MRD higher than or equal to 0.1% in adults and pediatric sufferers one month or older.
• Relapsed or refractory CD19-positive B-ALL in adults and pediatric sufferers one month or older.

Within the European Union (EU), BLINCYTO is indicated as monotherapy for the remedy of:

• Adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory B-ALL. Sufferers with Philadelphia chromosome-positive B-ALL ought to have failed remedy with at the least two tyrosine kinase inhibitors (TKIs) and haven’t any various remedy choices.
• Adults with Philadelphia chromosome-negative CD19-positive B-ALL in first or second full remission with MRD higher than or equal to 0.1%.
• Pediatric sufferers aged 1 yr or older with Philadelphia chromosome-negative CD19-positive B-ALL which is refractory or in relapse after receiving at the least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
• Pediatric sufferers aged 1 yr or older with high-risk first relapsed Philadelphia chromosome-negative CD19-positive B-ALL as a part of the consolidation remedy.

INDICATIONS

BLINCYTO ^® (blinatumomab) is indicated for the remedy of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in grownup and pediatric sufferers one month and older with:

• Philadelphia chromosome-negative illness within the consolidation section of multiphase chemotherapy.
• Minimal residual illness (MRD) higher than or equal to 0.1% in first or second full remission.
• Relapsed or refractory illness.

BLINCYTO ^® IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES together with IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

• Cytokine Launch Syndrome (CRS), which can be life-threatening or deadly, occurred in sufferers receiving BLINCYTO ^® . Interrupt or discontinue BLINCYTO ^® and deal with with corticosteroids as really useful.
• Neurological toxicities, together with immune effector cell-associated neurotoxicity syndrome (ICANS) which can be extreme, life-threatening, or deadly, occurred in sufferers receiving BLINCYTO ^® . Interrupt or discontinue BLINCYTO ^® as really useful.

Contraindications

BLINCYTO ^® is contraindicated in sufferers with a recognized hypersensitivity to blinatumomab or to any part of the product formulation.

Warnings and Precautions

• Cytokine Launch Syndrome (CRS): CRS, which can be life-threatening or deadly, occurred in sufferers receiving BLINCYTO ^® . The median time to onset of CRS is 2 days after the beginning of infusion and the median time to decision of CRS was 5 days amongst circumstances that resolved. Carefully monitor and advise sufferers to contact their healthcare skilled for indicators and signs of significant antagonistic occasions akin to fever, headache, nausea, asthenia, hypotension, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), elevated whole bilirubin (TBILI), and disseminated intravascular coagulation (DIC). The manifestations of CRS after remedy with BLINCYTO ^® overlap with these of infusion reactions, capillary leak syndrome (CLS), and hemophagocytic histiocytosis/macrophage activation syndrome (MAS). Utilizing all of those phrases to outline CRS in scientific trials of BLINCYTO ^® , CRS was reported in 15% of sufferers with R/R ALL, in 7% of sufferers with MRD-positive ALL, and in 16% of sufferers receiving BLINCYTO ^® cycles within the consolidation section of remedy. If extreme CRS happens, interrupt BLINCYTO ^® till CRS resolves. Discontinue BLINCYTO ^® completely if life-threatening CRS happens. Administer corticosteroids for extreme or life-threatening CRS.
• Neurological Toxicities , together with Immune Effector Cell-Related Neurotoxicity Syndrome: BLINCYTO ^® may cause severe or life-threatening neurologic toxicity, together with ICANS. The incidence of neurologic toxicities in scientific trials was roughly 65%. The median time to the primary occasion was throughout the first 2 weeks of BLINCYTO ^® remedy. The most typical (≥ 10%) manifestations of neurological toxicity had been headache and tremor. Grade 3 or increased neurological toxicities occurred in roughly 13% of sufferers, together with encephalopathy, convulsions, speech problems, disturbances in consciousness, confusion and disorientation, and coordination and stability problems. Manifestations of neurological toxicity included cranial nerve problems. The vast majority of neurologic toxicities resolved following interruption of BLINCYTO ^® , however some resulted in remedy discontinuation.

  The incidence of indicators and signs in step with ICANS in scientific trials was 7.5%. The onset of ICANS might be concurrent with CRS, following decision of CRS, or within the absence of CRS. There’s restricted expertise with BLINCYTO ^® in sufferers with energetic ALL within the central nervous system (CNS) or a historical past of neurologic occasions. Sufferers with a historical past or presence of clinically related CNS pathology had been excluded from scientific research. Sufferers with Down Syndrome over the age of 10 years could have the next threat of seizures with BLINCYTO ^® remedy.

  Monitor sufferers for indicators and signs of neurological toxicities, together with ICANS, and interrupt or discontinue BLINCYTO ^® as outlined within the PI. Advise outpatients to contact their healthcare skilled in the event that they develop indicators or signs of neurological toxicities.

• Infections: Roughly 25% of sufferers receiving BLINCYTO ^® in scientific trials skilled severe infections akin to sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, a few of which had been life-threatening or deadly. Administer prophylactic antibiotics and make use of surveillance testing as acceptable throughout remedy. Monitor sufferers for indicators or signs of an infection and deal with appropriately, together with interruption or discontinuation of BLINCYTO ^® as wanted.
• Tumor Lysis Syndrome (TLS), which can be life-threatening or deadly, has been noticed. Preventive measures, together with pretreatment unhazardous cytoreduction and on-treatment hydration, must be used throughout BLINCYTO ^® remedy. Monitor sufferers for indicators and signs of TLS and interrupt or discontinue BLINCYTO ^® as wanted to handle these occasions.
• Neutropenia and Febrile Neutropenia, together with life-threatening circumstances, have been noticed. Monitor acceptable laboratory parameters (together with, however not restricted to, white blood cell rely and absolute neutrophil rely) throughout BLINCYTO ^® infusion and interrupt BLINCYTO ^® if extended neutropenia happens.
• Results on Capacity to Drive and Use Machines: Resulting from the opportunity of neurological occasions, together with seizures and ICANS, sufferers receiving BLINCYTO ^® are in danger for lack of consciousness, and must be suggested in opposition to driving and fascinating in hazardous occupations or actions akin to working heavy or probably harmful equipment whereas BLINCYTO ^® is being administered.
• Elevated Liver Enzymes: Transient elevations in liver enzymes have been related to BLINCYTO ^® remedy with a median time to onset of three days. In sufferers receiving BLINCYTO ^® , though nearly all of these occasions had been noticed within the setting of CRS, some circumstances of elevated liver enzymes had been noticed outdoors the setting of CRS, with a median time to onset of 19 days. Grade 3 or higher elevations in liver enzymes occurred in roughly 7% of sufferers outdoors the setting of CRS and resulted in remedy discontinuation in lower than 1% of sufferers. Monitor ALT, AST, gamma-glutamyl transferase, and whole blood bilirubin previous to the beginning of and through BLINCYTO ^® remedy. BLINCYTO ^® remedy must be interrupted if transaminases rise to > 5 instances the higher restrict of regular (ULN) or if whole bilirubin rises to > 3 instances ULN.
• Pancreatitis: Deadly pancreatitis has been reported in sufferers receiving BLINCYTO ^® together with dexamethasone in scientific trials and the post-marketing setting. Consider sufferers who develop indicators and signs of pancreatitis and interrupt or discontinue BLINCYTO ^® and dexamethasone as wanted.
• Leukoencephalopathy: Though the scientific significance is unknown, cranial magnetic resonance imaging (MRI) modifications displaying leukoencephalopathy have been noticed in sufferers receiving BLINCYTO ^® , particularly in sufferers beforehand handled with cranial irradiation and antileukemic chemotherapy.
• Preparation and administration errors have occurred with BLINCYTO ^® remedy. Comply with directions for preparation (together with admixing) and administration within the PI strictly to reduce remedy errors (together with underdose and overdose).
• Immunization: Vaccination with stay virus vaccines isn’t really useful for at the least 2 weeks previous to the beginning of BLINCYTO ^® remedy, throughout remedy, and till immune restoration following final cycle of BLINCYTO ^® .
• Benzyl Alcohol Toxicity in Neonates: Critical antagonistic reactions, together with deadly reactions and the “gasping syndrome,” have been reported in very low start weight (VLBW) neonates born weighing lower than 1500 g, and early preterm neonates (infants born lower than 34 weeks gestational age) who acquired intravenous medication containing benzyl alcohol as a preservative. Early preterm VLBW neonates could also be extra prone to develop these reactions, as a result of they might be much less in a position to metabolize benzyl alcohol.

  Use the preservative-free preparations of BLINCYTO ^® the place attainable in neonates. When prescribing BLINCYTO ^® (with preservative) for neonatal sufferers, take into account the mixed every day metabolic load of benzyl alcohol from all sources together with BLINCYTO ^® (with preservative), different merchandise containing benzyl alcohol or different excipients (e.g., ethanol, propylene glycol) which compete with benzyl alcohol for a similar metabolic pathway.

  Monitor neonatal sufferers receiving BLINCYTO ^® (with preservative) for brand spanking new or worsening metabolic acidosis. The minimal quantity of benzyl alcohol at which severe antagonistic reactions could happen in neonates isn’t recognized. The BLINCYTO ^® 7-Day bag (with preservative) incorporates 7.4 mg of benzyl alcohol per mL.

• Embryo-Fetal Toxicity: Based mostly on its mechanism of motion, BLINCYTO ^® could trigger fetal hurt when administered to a pregnant girl. Advise pregnant girls of the potential threat to the fetus. Advise females of reproductive potential to make use of efficient contraception throughout remedy with BLINCYTO ^® and for 48 hours after the final dose.

Antagonistic Reactions

• The security of BLINCYTO ^® in grownup and pediatric sufferers one month and older with MRD-positive B-cell precursor ALL (n=137), relapsed or refractory B-cell precursor ALL (n=267), and Philadelphia chromosome-negative B cell precursor ALL in consolidation (n=165) was evaluated in scientific research. The most typical antagonistic reactions (≥ 20%) to BLINCYTO ^® on this pooled inhabitants had been pyrexia, infusion-related reactions, headache, an infection, musculoskeletal ache, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea.

Dosage and Administration Pointers

• BLINCYTO ^® is run as a steady intravenous infusion at a relentless movement fee utilizing an infusion pump which must be programmable, lockable, non-elastomeric, and have an alarm.
• It is vitally essential that the directions for preparation (together with admixing) and administration supplied within the full Prescribing Info are strictly adopted to reduce remedy errors (together with underdose and overdose).

Please see BLINCYTO ^® full Prescribing Info , together with BOXED WARNINGS.

About BiTE ^® Expertise
Bispecific T-cell Engager (BiTE ^® ) expertise is a focused immuno-oncology platform that’s designed to have interaction affected person’s personal T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eradicate detectable most cancers. The BiTE ^® immuno-oncology platform has the potential to deal with totally different tumor sorts by way of tumor-specific antigens. The BiTE ^® platform has a purpose of resulting in off-the-shelf options, which have the potential to make progressive T cell remedy accessible to all suppliers when their sufferers want it. Amgen is advancing a number of BiTE ^® molecules throughout a broad vary of hematologic malignancies and strong tumors, additional investigating BiTE ^® expertise with the purpose of enhancing affected person expertise and therapeutic potential. To be taught extra about BiTE ^® expertise, go to https://www.amgenoncology.com/bite-platform.html .

About Amgen
Amgen discovers, develops, manufactures and delivers progressive medicines to assist tens of millions of sufferers of their combat in opposition to a few of the world’s hardest illnesses. Greater than 40 years in the past, Amgen helped to determine the biotechnology business and stays on the cutting-edge of innovation, utilizing expertise and human genetic information to push past what’s recognized as we speak. Amgen is advancing a broad and deep pipeline that builds on its present portfolio of medicines to deal with most cancers, coronary heart illness, osteoporosis, inflammatory illnesses and uncommon illnesses.

In 2024, Amgen was named one of many “World’s Most Modern Firms” by Quick Firm and one in every of “America’s Finest Massive Employers” by Forbes, amongst different exterior recognitions . Amgen is without doubt one of the 30 corporations that comprise the Dow Jones Industrial Common ^® , and it is usually a part of the Nasdaq-100 Index ^® , which incorporates the biggest and most progressive non-financial corporations listed on the Nasdaq Inventory Market based mostly on market capitalization.

For extra data, go to Amgen.com and comply with Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .

Amgen Ahead-Trying Statements
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CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (traders)

Editor’s notice: Dr. Luger has acquired honoraria for an Amgen-sponsored instructional symposium.

1. Nationwide Most cancers Institute. Accessible at: https://seer.most cancers.gov/statfacts/html/alyl.html . Accessed on February 8, 2024 .
2. Terwilliger T, et al. Blood Most cancers J . doi:10.1038/bcj.2017.53.
3. Most cancers.org. Accessible at: https://www.most cancers.org/most cancers/sorts/acute-lymphocytic-leukemia/about/what-is-all.html Accessed on February 8, 2024 .
4. Leukemia & Lymphoma Society. Accessible at: https://www.lls.org/analysis/acute-lymphoblastic-leukemia-all#:~:textual content=Bpercent2DALLpercent20ispercent20morepercent20common,aboutpercent2075percent20percentpercent20ofpercent20cases . Accessed on February 8, 2024 .

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