On July 9, 2026 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported the launch of PTEN IHC CDx, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) for patients with prostate adenocarcinoma. The test identifies PTEN protein loss, also known as PTEN deficiency, in patients who may be eligible for AstraZeneca’s recently approved targeted therapy TRUQAP (capivasertib).1

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PTEN IHC CDx extends the company’s reach into urologic oncology, where community practices manage the majority of patients with advanced prostate cancer. Performed by NeoGenomics’ pathologists across its national oncology laboratory network, the test is available as a standalone order or as part of NEO PanTracer Pro for prostate cancer, a comprehensive molecular workup that combines CGP and cancer-type-directed IHC testing in a single order built to evolve with new treatment options.

"Clinicians treating this aggressive form of prostate cancer have long needed both a targeted therapy and a validated way to identify eligible patients," said Nathan Montgomery, Vice President, Medical Services, NeoGenomics. "With PTEN IHC CDx now integrated into NEO PanTracer Pro, community oncology practices have an FDA-approved companion diagnostic available through a single national laboratory partner, reflecting our commitment to providing the tools clinicians need for timely treatment decisions when new therapies become available."

Prostate cancer is the most common cancer in men in the United States, with more than 300,000 new cases and over 36,000 deaths annually.2 Of the approximately 35,000 patients diagnosed each year with mAPMN/S prostate cancer (formerly mHSPC), about one in four – or approximately 8,750 patients – have PTEN-deficient tumors.2,3 PTEN protein loss is detectable through a tissue-based test at the time of diagnosis.4

About PTEN IHC CDx
NeoGenomics’ IHC companion diagnostic assay detects PTEN protein loss in prostate adenocarcinoma tissue using the VENTANA PTEN (SP218) RxDx Assay. Authorized by the FDA to identify patients with mAPMN/S prostate cancer who may be eligible for TRUQAP, the test is performed by NeoGenomics pathologists across its national oncology laboratory network. PTEN IHC CDx is available as a standalone order, delivering results in as few as one to two days, or as part of NEO PanTracer Pro for prostate cancer, a comprehensive molecular workup offered in a single coordinated order that integrates CGP with cancer-type-directed IHC and ancillary testing for prostate carcinoma. The test has been approved in New York State.

(Press release, NeoGenomics Laboratories, JUL 9, 2026, View Source [SID1234669131])

On July 9, 2026 InxMed Co., Ltd ("InxMed"), a clinical-stage biotechnology company dedicated to developing innovative therapies targeting cancer treatment resistance and metastasis, reported that the clinical results of ifebemtinib (IN10018), a highly selective focal adhesion kinase (FAK) inhibitor, in combination with garsorasib (D-1553), a potent KRASG12C inhibitor in first-line KRASG12C-mutant NSCLC, have been published online in The Lancet Respiratory Medicine.

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The data were derived from a phase Ib/II trial evaluating the efficacy and safety of ifebemtinib plus garsorasib in KRASG12C-mutant solid tumors (NCT06166836/NCT05379946), where ifebemtinib plus garsorasib, as an all‑oral, chemotherapy‑free regimen, demonstrated impressive results in patients with first-line KRASG12C-mutant NSCLC.

Promising Antitumor Efficacy and Manageable Safety Profile

33 first-line NSCLC patients with KRASG12C-mutation were enrolled in the single-arm phase II cohort and received ifebemtinib (100mg once a day) and garsorasib (600mg twice a day) orally. By data cutoff on September 16, 2025 reported in this paper, the median follow-up duration was 21.5 months. Ifebemtinib in combination with garsorasib demonstrated a high response rate and durable responses in first-line KRASG12C-mutation NSCLC, increasing the possibility of a paradigm shift, which, if confirmed in currently ongoing phase 3 trial (NCT07174908), could substantially impact the current treatment options for this patient population.

Key findings published in this paper:

High Response Rates: Of the 33 enrolled patients, 31 were evaluable. The cORR was 82% (27/33) across all enrolled patients and 87% (27/31) among evaluable patients. And tumor shrinkage was observed in all evaluable patients, even in the patient with best overall response of PD.
Durable Responses: Among responders, the median Duration of Response (DOR) was Not Reached (NR) (95% CI: 15.2–NE), underscoring the potential of FAK inhibition to prevent or significantly delay treatment resistance.
Prolonged survival benefit of PFS and overall survival (OS): The mPFS reached an extraordinary 22.3 months (95% CI: 9.6–NE), with 12-month and 18-month PFS rates standing at 67.9% and 58.2%, respectively. The median OS was 27.8 months (95% CI: 27.8–NE), which remained immature as most patients was censored before 27.8 months. The 12-month and 24-month OS rates were 75.8% and 69.7%, respectively.
Manageable safety profile: All 33 patients experienced treatment-emergent adverse events (TEAE). Most of the TEAE were grade 1 or 2; grade 3 or 4 events occurred in 11 (33%) of 33 patients, of which eight (24%) were related to study drugs. No treatment-related death or treatment-related AEs leading to drug discontinuation were reported.
"The publication of our long-term follow-up data in The Lancet Respiratory Medicine serves as a momentous validation of our translational science," said Dr. Zaiqi Wang, Chairman and Chief Executive Officer of InxMed. "By pairing KRASG12C inhibitor with our FAK inhibitor ifebemtinib, we have succeeded in blocking this adaptively resistant pathway. An ORR of 82% and a median PFS of over 22 months in the first-line setting represents a paradigm shift, offering these patients a highly potent, completely chemotherapy-free and all-oral option."

Overcoming Resistance by FAK Inhibition When Targeting KRASG12C

KRASG12C mutations occur in roughly 12-14% of NSCLC cases. Currently there were six KRASG12C inhibitors approved in previously-treated KRASG12C-mutant NSCLC, including sotorasib and adagrasib (approved in the USA and Europe) and fulzerasib, garsorasib, glecirasib and sosimerasib (approved in China). However, no KRASG12C inhibitors monotherapy or combination regimens were approved in first-line settings partially due to primary or acquired resistance when targeting KRASG12C alone. InxMed’s translational research showed that KRASG12C inhibition alone triggers adaptive hyperactivation of the FAK‑YAP signaling pathway, promotes fibrogenesis in the tumor microenvironment, and thereby enhances tumor cell survival. And FAK inhibition by Ifebemtinib disrupts this resistance mechanism, sensitizing tumor cells to KRASG12C inhibition and prolonging the duration of treatment response.

Based on these promising clinical data, ifebemtinib has been granted Breakthrough Therapy Designation (BTD) in first-line NSCLC harboring KRASG12C mutation from the China National Medical Products Administration (NMPA). InxMed is progressing its clinical development plan, including an ongoing randomized Phase III confirmatory trial (NCT07174908) intended to support the adoption of this all‑oral, chemotherapy-free regimen as a new standard of care in the front‑line setting.

Based on a robust translational medicine foundation and compelling clinical evidence, Ifebemtinib is poised to become a revolutionary therapeutic that could fundamentally reshape the RAS-targeted treatment paradigm. InxMed is strategically driving a comprehensive development program for Ifebemtinib across RAS-mutant tumors, with combination regimens already initiated or in preparation not only with KRAS G12C inhibitors, but also with KRASG12D inhibitors and multi‑RAS inhibitors, among other novel classes, underscoring the company’s commitment to transforming the future of RAS-addicted cancers.

About Ifebemtinib (IN10018)

Ifebemtinib (IN10018) is an orally available, highly potent, and selective small-molecule inhibitor of focal adhesion kinase (FAK). InxMed holds exclusive global development and commercialization rights. Clinically, ifebemtinib has demonstrated excellent safety and tolerability in over 700 subjects globally, showing vast potential as a "backbone" combination partner across multiple modalities, including RAS inhibitors, immune checkpoint blockades, and antibody-drug conjugates (ADCs). It has received multiple Breakthrough Therapy Designations from the NMPA and Fast Track Designation from the U.S. FDA.

(Press release, InxMed, JUL 9, 2026, View Source [SID1234669130])

On July 9, 2026 Freenome, an early cancer detection company developing blood-based screening tests, reported favorable results from its pivotal clinical validation study assessing the performance of assay and algorithm improvements for its updated version of the SimpleScreen CRC blood-based colorectal cancer (CRC) screening test.

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The study successfully met its primary and secondary endpoints. The updated test showed 18.2% sensitivity for detecting advanced precancerous lesions (APLs), 41.9% sensitivity for APLs with high-grade dysplasia (HGD), and 80.4% sensitivity for detecting CRC, including 52% of Stage I cases (Stage I (T1) 39.9% and Stage I (T2) 81.2%), 100% of Stage II, 97.3% of Stage III and 100% of Stage IV. The results were adjusted to the age and sex distribution of the U.S. Census to better reflect the intended use population, and specificity for no findings on colonoscopy was 90%.

CRC remains the second-leading cause of cancer-related death in the United States, yet more than 50 million eligible adults are not up to date on recommended screening. Blood-based screening tests have the potential to reach people who might otherwise remain unscreened.

The clinical validation of the updated SimpleScreen CRC test includes blinded, previously unevaluated samples from participants who enrolled in PREEMPT CRC1 — a prospective, registrational study — as well as previously tested samples. Conducted at more than 200 sites, the PREEMPT CRC study enrolled 48,995 asymptomatic, average-risk adults between the ages of 45 and 85 scheduled to undergo a screening colonoscopy. The analysis included more than 85 individuals with CRC, 1,500 with APLs, and 150 with APLs with HGD.

Endpoint

Updated SimpleScreen CRC
CV study2

(US Census Weighted Endpoints)

SimpleScreen CRC in
PREEMPT CRC study1

(US Census Weighted Endpoints)

N

Value (95% CI)

N

Value (95% CI)

Sensitivity for CRC (Primary)

89

80.4%

(70.2%, 87.7%)

72

81.1%

(71.3%, 88.1%)

Sensitivity for APL (Primary)

1570

18.2%

(16.3%, 20.4%)

2567

13.7%

(12.4%, 15.0%)

Sensitivity for HGD (APL 2.1)

(Secondary)

157

41.9%

(34.0%, 50.3%)

110

30.5%

(22.7%, 39.5%)

Detecting APLs, particularly those with HGD, is important because these lesions are more likely to progress to CRC if left untreated. The sensitivity results for APL and APL with HGD demonstrated in this study are the highest reported to date for any non-invasive screening blood test in a prospective registrational pivotal clinical study.

"The sensitivity for APL and APL with HGD for the updated SimpleScreen CRC test is a marked improvement and gets us closer to matching the performance of certain stool-based CRC screening tests, with potentially higher adherence," noted Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study.

With the improved detection of APLs and HGD, our published model3 suggests that the updated test would result in 7.7% more life-years gained, 9.5% more cases of cancer prevented, and 9.5% more cancer deaths prevented, compared to the first-generation CRC test version.4

"This study marks a major milestone in our mission to advance blood-based colorectal cancer screening," said Aaron Elliott, Ph.D., CEO of Freenome. "The significant improvement in detecting precancerous lesions demonstrates the critical role our SimpleScreen CRC platform can play in early detection and prevention of colon cancer. With millions of eligible Americans still not getting screened, expanding access to accurate, non-invasive screening options that patients are more likely to complete has never been more important."

Freenome submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) in August 2025 for the first-generation version of its SimpleScreen CRC test. The FDA is expected to complete its review in mid 2026. Freenome intends to submit a supplemental PMA to the FDA for the next-generation SimpleScreen CRC test.

In August 2025, Freenome and Abbott entered into a commercial collaboration agreement to bring SimpleScreen CRC to market. Upon FDA approval, SimpleScreen CRC will be exclusively commercialized and made available by Abbott. Freenome will be offering a multi-cancer product consisting of SimpleScreen CRC in combination with its SimpleScreen Lung laboratory-developed test solely to patients who are eligible for both screenings.

The commercial collaboration agreement included a milestone payment tied to the outcome of this study. That intended milestone payment will be set at $70 million, pending FDA approval of the next-generation test and the successful technology transfer of the product to Abbott. Freenome and Abbott are collaborating on a multi-year R&D program focused on improving assay performance.

"These results strengthen our confidence in the role blood-based colorectal cancer screening can play in expanding screening," said Jake Orville, senior vice president of Abbott’s cancer diagnostics business. "Combined with Abbott’s preferred, guideline-supported screening option, we’re uniquely positioned to offer healthcare providers and patients a differentiated colorectal cancer screening portfolio built on innovation, performance and choice—with one goal in mind: helping more people get screened."

While the foundational SimpleScreen CRC test will provide a robust, clinically validated screening option for patients, Freenome continues to advance its next-generation pipeline of single- and multi-cancer tests. Through its pioneering Personalized Cancer Detection approach to screening, Freenome will be matching blood-based screening tests to the cancers most relevant to individuals based on their health profile, while leveraging its multiomics platform to optimize test performance for additional validated indications.

(Press release, Freenome, JUL 9, 2026, View Source [SID1234669129])

On July 9, 2026 Blue Earth Therapeutics, a clinical-stage radiopharmaceutical company and University College London (UCL) reported initiation of a Phase 1 clinical trial (NCT07414940) evaluating Actinium (225Ac) rhPSMA-10.1 Injection, an investigational alpha‑emitting PSMA‑targeted radiopharmaceutical for the treatment of patients within clinical trials in metastatic castrate‑resistant prostate cancer (mCRPC). The study is sponsored by UCL and is being conducted at UCL Hospital, London. Blue Earth Therapeutics is providing funding and supply of investigational drug product.

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This Phase 1 study is designed to evaluate the safety and anti-tumour activity of Actinium (225Ac) rhPSMA-10.1 Injection in participants with PSMA‑positive mCRPC whose disease has progressed following prior therapy. Results from the study are expected to characterise the side effects of Actinium (225Ac) rhPSMA-10.1 Injection and to inform dose selection for subsequent research.

Alpha-emitting radionuclides such as actinium-225 (225Ac) deliver a high amount of energy over a short distance in tissue, causing irreparable DNA damage to targeted cancer cells whilst aiming to limit exposure to surrounding healthy tissue. When incorporated into a PSMA-targeting molecule such as rhPSMA-10.1, this approach is designed to deliver localised radiation directly to prostate cancer lesions, potentially offering a targeted treatment strategy for patients with advanced cancer.

Actinium (225Ac) rhPSMA-10.1 Injection is the second clinical candidate in Blue Earth Therapeutics’ oncology pipeline, building on the company’s ongoing Lutetium (¹⁷⁷Lu) rhPSMA‑10.1 Injection clinical programme, which is currently in a Phase 2 clinical trial. Together, these programmes reflect the company’s work across both alpha‑ and beta‑emitting radiopharmaceutical therapies using its radiohybrid PSMA platform.

UCL Cancer Institute director Professor Gert Attard said: "This study is an important step in advancing more precise treatment options for men with metastatic castrate-resistant prostate cancer. The combination of a highly targeted PSMA approach with the potent, short-range effects of an alpha-emitting radionuclide offers a promising strategy to deliver meaningful anti-tumour activity while limiting toxicity. Early-phase trials such as this are essential for determining safety, refining dose and guiding how these therapies can be integrated into personalised treatment pathways to improve outcomes for patients."

"Initiation of this collaborative Phase 1 study represents an important milestone for Blue Earth Therapeutics and our investigational radiopharmaceutical therapy pipeline," said Dr David Gauden, Chief Executive Officer of Blue Earth Therapeutics. "Building on our clinical experience in both alpha‑ and beta‑emitting radiopharmaceutical therapies, we are combining the targeting precision of rhPSMA with the alpha‑emitting properties of actinium‑225 to explore a potential treatment approach for patients with advanced prostate cancer. We are very grateful to the team at UCL and to their patients for undertaking this study."

About metastatic prostate cancer

It has been forecast that in 2025 there would be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).1 Five-year survival for newly diagnosed metastatic prostate cancer is low, 40.1%.2 While death rates from prostate cancer have declined over the past three decades2, there is still considerable room to improve patient outcomes.

About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA)

rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabelled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.

(Press release, Blue Earth Therapeutics, JUL 9, 2026, View Source [SID1234669128])

On July 9, 2026 Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, reported that the U.S. Food and Drug Administration (FDA) has approved ENNUMO (pegfilgrastim-pccg), a biosimilar to NEULASTA (pegfilgrastim). ENNUMO is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).1 ENNUMO is approved by the FDA for the same indications as its reference product, NEULASTA.

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With this approval, Accord BioPharma is now the only company in the U.S. offering two distinct pegfilgrastim biosimilars — ENNUMO and UDENYCA (pegfilgrastim-cbqv) — alongside FILKRI (filgrastim-laha), its short-acting granulocyte colony-stimulating factor (G-CSF) biosimilar approved in February 2026. Together, these three products form a G-CSF portfolio designed to meet the diverse clinical and operational needs of oncology practices, hospitals, and the patients they serve.

"Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies," said Chrys Kokino, President, Accord North America. "With ENNUMO, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company. We are on track to deliver 20 biosimilars by 2030. We recognize that both patients and oncology practices are counting on us for the long term as we expand our oncology product offerings. Most importantly we are proud that we have and will continue to increase patient access to these critically important medicines."

Expanding Access Through Portfolio Breadth
Febrile neutropenia is one of the most serious and frequently occurring complications of myelosuppressive chemotherapy, contributing to treatment delays, dose reductions, hospitalizations, and increased mortality risk in patients with cancer.2 Granulocyte colony-stimulating factors have become a cornerstone of oncology supportive care, and biosimilars are playing an increasingly critical role in expanding access to these therapies across a range of clinical settings.

"From speaking with our customers, we know the needs of oncology practices are not one-size-fits-all, and we’ve built our portfolio to address this reality," said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. "With ENNUMO and UDENYCA, we have pegfilgrastim biosimilar options to offer—alongside FILKRI for short-acting G-CSF—so we can meet physicians and their patients where they are."

Part of a Broader Biosimilar Growth Story
The approval of ENNUMO marks the latest milestone in Accord BioPharma’s rapid portfolio expansion. The company has set a strategic goal to launch 20 biosimilar products in the U.S. by 2030, building on a growing commercial portfolio that now spans oncology and immunology, with an aim to further expand into central nervous system therapies. Backed by Intas Pharmaceuticals, Ltd., one of the world’s largest and most experienced biosimilar developers with nearly five decades of global pharmaceutical expertise, Accord BioPharma is uniquely positioned to deliver on this ambition.

"ENNUMO’s approval is another proof point that what we’re building at Accord BioPharma can genuinely change the treatment landscape for patients in the U.S.," said Binish Chudgar, Chairman and Managing Director, Intas Pharmaceuticals, Ltd. "Our goal of 20 biosimilars by 2030 is not just a number. It reflects the depth of our pipeline and our determination to deliver."

Contact: [email protected]

IMPORTANT SAFETY INFORMATION

Contraindications: ENNUMO is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

Splenic Rupture: Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Patients who report left upper abdominal or shoulder pain after receiving ENNUMO should be evaluated for an enlarged spleen or splenic rupture.

Acute Respiratory Distress Syndrome: Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients for ARDS who develop fever, lung infiltrates or respiratory distress after receiving ENNUMO. Discontinue ENNUMO in patients with ARDS.

Serious Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial therapies to manage the reaction. Permanently discontinue ENNUMO in patients with serious hypersensitivity reactions.

Use in Patients with Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue ENNUMO if sickle cell crisis occurs.

Glomerulonephritis: Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause and if likely, consider dose-reduction or interruption of ENNUMO.

Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during ENNUMO therapy is recommended.

Thrombocytopenia: Pegfilgrastim products can cause thrombocytopenia. Monitor platelet counts during ENNUMO therapy.

Capillary Leak Syndrome: Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Closely monitor patients who develop symptoms of capillary leak syndrome and provide standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The G-CSF receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis: Aortitis has been reported in patients receiving pegfilgrastim products and may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue ENNUMO if aortitis is suspected.

Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy, including pegfilgrastim products, has been associated with transient positive bone imaging changes and should be considered when interpreting bone imaging results.

Most Common Adverse Reactions:

Most common adverse reactions (≥ 5% higher difference in incidence compared to placebo) are bone pain and pain in extremity.

INDICATIONS

ENNUMO is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older to:

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use:

ENNUMO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

ENNUMO (pegfilgrastim-pccg) injection for manual use is supplied in a 6 mg/0.6 mL single-dose prefilled syringe.

Click here for full Prescribing Information.

NEULASTA (pegfilgrastim) is a registered trademark of Amgen Inc.

(Press release, Accord BioPharma, JUL 9, 2026, View Source [SID1234669127])