On May 31, 2022 Fresenius Kabi reported the immediate availability in the U.S. of PEMEtrexed for Injection, USP, a new generic equivalent to Alimta (Press release, Fresenius Kabi Oncology, MAY 31, 2022, View Source [SID1234615286]). Fresenius Kabi produces its PEMEtrexed for Injection, USP in the United States, where the company offers the most comprehensive injectable oncology portfolio of any pharmaceutical manufacturer.

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Fresenius Kabi PEMEtrexed for Injection, USP is an affordable treatment option for adult patients with non-squamous non-small cell lung cancer and malignant pleural mesothelioma.

Available in four presentations for intravenous (IV) use, Fresenius Kabi now has the broadest portfolio of PEMEtrexed for Injection, USP products available from any manufacturer in the U.S., including two new strengths designed to help streamline pharmacy operations and reduce drug waste:

PEMEtrexed for Injection, USP 100 mg per single-dose vial
PEMEtrexed for Injection, USP 500 mg per single-dose vial
New strength: PEMEtrexed for Injection, USP 750 mg per single-dose vial
New strength: PEMEtrexed for Injection, USP 1 gram per single-dose vial
"We are pleased to introduce another generic chemotherapy medication to help make cancer treatments more accessible and affordable for patients," said John Ducker, president and CEO of Fresenius Kabi USA. "And we’re proudly producing our PEMEtrexed for Injection here in the U.S."

Fresenius Kabi offers more than 30 different oncology drugs in the U.S., and nearly 90 percent are formulated, filled and finished in the U.S. PEMEtrexed for Injection, USP is the newest example of the company’s commitment to investing "More in America." This effort is focused on providing more supply, more science, more support and more care to its customers and the patients they serve in the U.S. Fresenius Kabi has invested nearly $1 billion to modernize and expand advanced U.S. pharmaceutical production and distribution facilities.

PEMEtrexed for Injection, USP, along with other oncology medicines, is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program that offers copay assistance to eligible U.S. patients. The program can lower out-of-pocket costs to as little as $0 per month for eligible patients. To determine eligibility, patients should speak to their physician. Enrollment is a simple online process. Details can be found on the KabiCare website at kabicare.us.

Important Safety Information

INDICATIONS AND USAGE

Pemetrexed for Injection is a folate analog metabolic inhibitor indicated:

in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.
initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
IMPORTANT SAFETY INFORMATION

Pemetrexed for Injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed.

Myelosuppression: Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer pemetrexed for injection when the absolute neutrophil count is less than 1500 cells/mm3 and platelets are less than 100,000 cells/mm3. Initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of pemetrexed for injection.

Renal Failure: Can cause severe, and sometimes fatal, renal failure. Do not administer when creatinine clearance is less than 45 mL/min.

Bullous and Exfoliative Skin Toxicity: Permanently discontinue for severe and life-threatening bullous, blistering or exfoliating skin toxicity.

Interstitial Pneumonitis: Withhold for acute onset of new or progressive unexplained pulmonary symptoms. Permanently discontinue if pneumonitis is confirmed.

Radiation Recall: Can occur in patients who received radiation weeks to years previously; permanently discontinue for signs of radiation recall.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

The most common adverse reactions (incidence ≥ 20%) of pemetrexed for injection, when administered as a single agent are fatigue, nausea, and anorexia.

The most common adverse reactions (incidence ≥ 20%) of pemetrexed for injection when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation.

The most common adverse reactions (incidence ≥ 20%) of pemetrexed for injection when administered in combination with pembrolizumab and platinum chemotherapy are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Ibuprofen increased risk of pemetrexed for injection toxicity in patients with mild to moderate renal impairment. Modify the ibuprofen dosage as recommended for patients with a creatinine clearance between 45 mL/min and 79 mL/min.

On May 31, 2022 Median Technologies (Paris:ALMDT) reported that the company is expanding its portfolio of services with Imaging Lab, a new entity whose mission is to leverage AI, data mining, and radiomics technologies to exploit imaging data from clinical trials in oncology (Press release, MEDIAN Technologies, MAY 31, 2022, View Source [SID1234615284]).

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The creation of Imaging Lab materializes the convergence of iCRO’s activities for image management in the development of new oncologic drugs and iBiopsy’s activities for the development of software as medical device targeting early diagnosis of cancers, especially lung cancer.

"We are seeing a paradigm shift of pharmaceutical companies towards new drug candidates targeting patients with early-stage cancers," said Fredrik Brag, CEO and founder of Median Technologies. "The synergy between our iCRO and iBiopsy businesses is perfect to respond to this change: iBiopsy develops software as medical device, integrating AI technologies, which allow the diagnosis of diseases at a very early stage, when patients are still asymptomatic. At the same time, iCRO has extensive knowledge of image processing and its management in clinical trials. The cross-fertilization of our two businesses will enable us to leverage imaging data in conjunction with other clinical information in an unparalleled way and provide biopharmaceutical companies with tools for Go/No-Go decisions in trials," adds Fredrik Brag.

Imaging Lab will provide new answers in four areas that determine the success of clinical trials: selection of patients included in trials, especially inclusion of patients diagnosed at early stages of disease thanks to AI technologies, prediction of response to therapy, measurement of disease progression, and evaluation of the safety of drug candidates. The goal is to optimize development plans, including facilitating Go/No-Go decisions to increase the success rate of clinical trials. This rate is especially low in oncology, generating an average development cost of $2.8 billion to take a new molecule to market, compared with an average of $1 billion per new molecule brought to market for other therapeutic areas1.

"Our experience of image management in clinical trials has shown that trial data is vastly underutilized. We can extract much more information from images through the widescale use of data mining, AI, and radiomics and use these technologies to better support our customers and biopharmaceutical partners in their clinical developments," says Nicolas Dano, COO iCRO of Median Technologies.

The Imaging Lab team will be present from June 4-6 (exhibition dates) at the ASCO (Free ASCO Whitepaper) Annual Conference in Chicago , Median’s booth #2098, Exhibit Hall A, to meet the pharmaceutical community.

On May 31, 2022 Pillar Biosciences, the leader in Decision Medicine, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and overall testing costs, reported that its abstract, "Reducing Pre-analytical Sample QC Failure Rates for Cancer Molecular Genetic Assays with SLIMamp Technology", has been published online in the Journal of Clinical Oncology, in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Pillar Biosciences, MAY 31, 2022, View Source [SID1234615283]). The company will also be showcasing its highly accurate and sensitive NGS genetic testing technology at booth #17157 June 4 through June 6, 2022.

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"There is a critical need for NGS tests that can accurately and rapidly identify somatic variants in cancer patients. Current NGS tests can have high failure rates which delay the return of actionable results to physicians, significantly impacting time to diagnosis and critical treatment decisions," said Randy Pritchard, CEO of Pillar Biosciences. "The findings from our study underscore the accuracy and reliability of our SLIMamp technology and demonstrate its ability to generate highly accurate results from lower quality samples that have failed other NGS tests. We are pleased that this study has been published online and look forward to demonstrating the capabilities of our NGS genetic testing solutions at ASCO (Free ASCO Whitepaper)."

In the study, 48 tumor samples failing one or more pre-analytical quality control (QC) sample parameters for whole exome sequencing (WES) from an accredited diagnostic genomics laboratory were sequenced using Pillar Bioscience’s oncoReveal Solid Tumor Panel. Results demonstrated that the panel achieved high sequencing coverage (>3,000X) for all 48 samples and was able to generate clinical reports for 45 samples (94%). 38 of these reports (79%) contained clinically actionable or significant variants that would not have otherwise been identified with currently available panels. The study showed that oncoReveal Solid Tumor Panel with Pillar Biosciences’ proprietary SLIMamp technology, was able to generate reliable, interpretable results for almost all of the samples that had failed pre-analytical QC for WES.

At booth #17157, Pillar Biosciences will also be featuring the company’s extensive portfolio of NGS genetic testing solutions, including the oncoReveal Dx Lung and Colon Cancer Assay, PillarHS Multi-Cancer Panel, Essential MPN Panel, Multi-Cancer with CNV and RNA Fusion Panel, and Myeloid Panel.

On May 31, 2022 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it will present data at two upcoming scientific congresses this spring: the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 3-7 in Chicago, Ill. and the 30th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), June 9-12 in Vienna, Austria (Press release, Takeda, MAY 31, 2022, View Source [SID1234615282]). Takeda’s latest research in oncology focuses on enhancing and improving patient care while exploring novel approaches for patients with limited treatment options.

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Data presentations span a range of cancers, including lymphoma, leukemia, multiple myeloma and non-small cell lung cancer, including early insights into investigational therapies that leverage the innate immune system.

"Our data at this spring’s medical congresses are indicative of our quest to outsmart cancer and our ability to work collaboratively with partners to further our research capabilities," said Christopher Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda. "In addition to sharing data on currently approved therapies, we look forward to presenting early findings from our innate immunity clinical programs – many of which are exploring novel mechanisms of action – that we believe have the power to advance the field of oncology and recast current standards of care."

A full list of company-sponsored abstracts are available for ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

On May 31, 2022 Eureka Therapeutics Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat solid tumors, and City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that City of Hope treated the first patient with GPC3-positive advanced hepatocellular carcinoma (HCC), the predominant type of liver cancer, with ECT204, an experimental T cell therapy (Press release, Eureka Therapeutics, MAY 31, 2022, View Source [SID1234615281]). This marks the first-in-human use of GPC3 targeting ARTEMIS T cells for the treatment of HCC.

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Glypican 3 (GPC3) is a promising target for HCC therapies and is found in more than 70% of HCC cells. The GPC3 protein is also expressed in other solid tumors, including ovarian and lung cancer. During the ARYA-3 investigational study evaluating ECT204, a patient’s T cells are collected, engineered to express Eureka’s proprietary ARTEMIS cell receptors targeting GPC3, and infused back into the patient’s body to target and kill GPC3-expressing cancer cells. In January of this year, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to ECT204 for the treatment of HCC. Additional information about this Phase I/II study may be found at ClinicalTrials.gov using Identifier NCT: NCT04864054.

"First patient dosing of ECT204 is a significant step forward in our commitment to expand the use of T cell therapy into solid tumors," said Dr. Cheng Liu, founder and CEO, Eureka Therapeutics. "ARTEMIS T cells have demonstrated superior tumor infiltration and excellent safety profile in preclinical studies. We look forward to further developing it in the clinical setting to fully unlock the potential of T-cell therapy in solid tumors."

"City of Hope is committed to finding innovative treatments for challenging solid tumors that currently do not have effective medical treatments," said Daneng Li, M.D., co-director of the Neuroendocrine Tumor Program and principal investigator of the ARYA3 trial at City of Hope. "Targeting GPC3 with T cell immunotherapy would be a promising approach to treating advanced liver cancer."

Liver cancer is the fourth leading cause of cancer deaths worldwide, accounting for an estimated 830,000 deaths in 2020. About 41,000 new cases and nearly 31,000 deaths from liver cancer are expected to occur in the U.S. in 2022. According to the American Cancer Society, liver cancer diagnosis has more than tripled since 1980. Patients with advanced HCC have a poor prognosis and limited treatment options.

"Liver cancer patients have very limited treatment options, and more innovative therapies with novel mechanisms of action are desperately needed to bring hope to patients with this challenging diagnosis," Li said. "I look forward to treating more patients with this experimental therapy and seeing data from the study to understand the potential of ECT204."

Patients, caregivers and health care professionals interested in Eureka’s clinical trials and technology can find more information by visiting eurekaconnectme.com.