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FDA Approves New FoundationOne®Liquid CDx Companion...

(Foundation Medicine) Oct 27, 2020 - Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Found...

U.S. Preventive Services Task Force Issues Draft Recomm...

(USPSTF) Oct 27, 2020 - The U.S. Preventive Services Task Force (Task Force) today posted a draft recommendation statement on screening for co...

Exact Sciences To Acquire Thrive Earlier Detection, Bec...

(Exact Sciences) Oct 27, 2020 - Brings together cancer screening R&D pioneers to transform the future of cancer diagnostics and impact liv...

Enhertu Granted Priority Review in the US for the Treat...

(AstraZeneca) Oct 28, 2020 - AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has receive...

Genetic Alterations May Contribute to Greater Prostate ...

(AACR) Oct 28, 2020 - Prostate cancer tumors from African American men had higher frequencies of certain genetic alterations that may be assoc...

Featured Content

Nicholas James, MD, PhD, offers a summary of the STAMPEDE study to date

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center, and Geoffrey Ku, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center, discuss recent clinical developments in gastric and esophageal cancer

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center, and Victoria Villaflor, MD, Clinical Professor, Director Head and Neck Oncology at City of Hope, discuss unresectable stage III Non Small Cell Lung Cancer (www.azioinpractice.com)

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Bradley McGregor, MD, Clinical Director, Lank Center for Genitourinary Oncology, Professor of Medicine, Harvard Medical School, discuss Checkmate 9ER and other I-O studies as they pertain to the management of RCC patients

The recent ACCC national meeting showcased practice changes made by community cancer centers to improve quality care in these challenging times. Find out how initiatives expanding the clinical role of oncology pharmacists, gaining access to real-time hospital data to rein in costs, and moving chemotherapy to the outpatient setting are changing the dynamic...

Five large phase 3 trials at ESMO in diverse, generally hard-to-treat solid tumors were considered practice-changing by most experts. PROfound showed the overall survival benefit of a PARP inhibitor for HRR gene-mutated mCRPC, while in monarchE, the disease-free survival benefit seen with the use of a CDK4/6 inhibitor in the adjuvant setting in early, hig...

At ESMO, researchers were excited about lung cancer data presented from trials such as KEYNOTE-024 and EMPOWER-Lung 1. Read on to see what study outcomes are poised to move the needle for treating patients with lung cancer.

Treatment in many patients with unresectable Stage III non-small cell lung cancer (NSCLC) can now be administered with curative intent – but despite the opportunity to treat with this goal, less than 50 percent of patients with Stage III NSCLC actually receive this curative intent treatment.

Podcasts

Renal Cell Carcinoma (RCC) - Bradley McGregor, MD, and Robert Figlin, MD, discuss clinical highlights from ESMO 2020

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Non Small Cell Lung Cancer – Victoria Villaflor, MD, and Robert Figlin, MD, discuss unresectable stage III NSCLC

10/21/20

Gastric/GE Junction Cancer – Geoffrey Ku, MD, and Robert Figlin, MD, discuss recent clinical developments in ga...

10/16/20

Breast Cancer - Sara Hurvitz, MD, and Robert Figlin, MD, discuss recent clinical developments in early stage and late...

07/17/20

Adjuvant Lung Cancer - Roy Herbst, MD, and Robert Figlin, MD, discuss the recent ASCO20 plenary presentation of the A...

06/25/20

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Cristina Suárez, MD, on the promise of I-O in advanced renal cell carcinoma

David Roberge, MD, explains rationale for the design of the CE.7 trial

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October 2020 Edition

Treatment in many patients with unresectable Stage III non-small cell lung cancer (NSCLC) can now be administered with curative intent – but despite the opportunity to treat with this g...

October 2020 Edition

Five large phase 3 trials at ESMO in diverse, generally hard-to-treat solid tumors were considered practice-changing by most experts. PROfound showed the overall survival benefit of a PAR...

October 2020 Edition

At ESMO, researchers were excited about lung cancer data presented from trials such as KEYNOTE-024 and EMPOWER-Lung 1. Read on to see what study outcomes are poised to move the needle fo...

October 2020 Edition

The recent ACCC national meeting showcased practice changes made by community cancer centers to improve quality care in these challenging times. Find out how initiatives expanding the cli...

Blog

ASCO 2020 Highlights for Sunday

May 31, 2020

Sunday’s live broadcast of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting featured late-breaking data fr...

ASCO 2020 Highlights for Saturday

May 30, 2020

The live broadcast of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting kicked off this morning with highligh...

Sneak Peek at ASCO 2020 Plenary Sessions

May 29, 2020

Ahead of this weekend’s live broadcast of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, late-breaking ...

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Stemming from the user preference that you set, stay informed and increase your productivity via 27/7 web based access to Ontelligence^TM and a customized email alert system summarizing the most recent oncology-specific information available.

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The Oncology Business Dynamics Learning Platform addresses the need to have a high level of understanding of the non-clinical issues that are influencing the decision making process for hem/oncs today.

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Oncology Events Calendar

October 28, 2020

Caregiving for Your Loved One Living with Metastatic Triple Negative Breast Cancer: Part II of Life with Metastatic Triple Negative Breast Cancer (CancerCare Connect Education Workshop)

(by phone or via webcast)

November 3, 2020

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
Nov 16	Bristol-Myers Squibb, lisocabtagene maraleucel (liso-cel) The company provided an update on May 6, 2020 regarding its BLA submission to the FDA for liso-cel and said that the PDUFA action date of Aug. 17, 2020 had been extended by three months to Nov. 16, 2020. The FDA requested additional information following its acceptance of the company's marketing application for liso-cel, which would require additional time for U.S. regulators to review, the company said. BMS previously announced on Feb. 13, 2020 that the FDA had accepted for Priority Review its BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed CAR T-cell product, for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The BLA is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, a phase 1 trial evaluating liso-cel in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma. That trial is the largest study of CD19-directed CAR T cells to support a BLA to date with results presented at the 2019 ASH annual meeting. Liso-cel has not yet been approved for use in any country.
Nov 28	Merck , Keytruda® (pembrolizumab) Merck announced on July 30, 2020 that the FDA had accepted and granted priority review to a new sBLA seeking accelerated approval for pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10). The application for metastatic TNBC is based on the phase 3 KEYNOTE-355 trial. In that trial, pembro plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy alone in patients whose tumors expressed PD-L1 at CPS ≥10 who comprised about 38% of patients enrolled in the study. These data were presented at ASCO 2020. The trial will continue without changes to evaluate the other dual primary endpoint of overall survival (OS). The submission marks one of the first U.S. marketing applications for Keytruda in breast cancer. The FDA has set a PDUFA, or target action, date of Nov. 28, 2020.
Dec 18	MacroGenics, margetuximab The company said on May 28, 2020 that during a recent mid-cycle communication with the FDA the Agency said it is no longer planning to hold an ODAC meeting to discuss the BLA for margetuximab. The FDA also reaffirmed that it anticipates meeting the PDUFA goal date of Dec. 18, 2020 for the review of MacroGenics' application. The company is seeking approval of margetuximab, a monoclonal antibody targeting HER2, for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results from the pivotal phase 3 SOPHIA study, evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have received prior anti-HER2 therapies. Updated results from the study were presented at the SABCS 2019. Final OS analysis is planned after 385 events and is expected to occur in the second half of 2020.
Dec 27	Mylan / Biocon, MYL-1402O The FDA accepted a biologics license application (BLA) for a proposed biosimilar of Avastin (bevacizumab), according to an announcement by Mylan during its fourth quarter 2019 earnings call. Biocon subsequently issued a press release on Mar. 9, 2020. Mylan also said that it had submitted a European application for the bevacizumab biosimilar. The BLA seeks approval of bevacizumab for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line use for patients with non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent or metastatic cervical cancer. The BLA is supported by a global randomized, controlled phase 3 clinical trial evaluating the efficacy, safety and immunogenicity of the proposed biosimilar vs. Avastin. The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Dec. 27, 2020.
Dec 31	Samsung Bioepis Co., SB-8 Samsung Bioepis Co. announced on Nov. 11, 2019 that the FDA had accepted for review the BLA for SB-8, a biosimilar candidate referencing Roche's Avastin (bevacizumab). If approved, SB-8 will be commercialized in the U.S. by Merck & Co. An approval decision is anticipated in Q4 2020.

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Today's Oncology News

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Oncology Events Calendar

Caregiving for Your Loved One Living with Metastatic Triple Negative Breast Cancer: Part II of Life with Metastatic Triple Negative Breast Cancer (CancerCare Connect Education Workshop)

Caregiving for Your Loved One Living with Cancer (CancerCare Connect Education Workshop)

Society for Immunotherapy of Cancer Annual Meeting & Pre-Conference (SITC 2020)

2020 Hematology/Oncology Program Directors' Retreat (ASCO)

12th European Multidisciplinary Congress on Urological Cancers (EMUC20) (ESMO, ESTRO & EAU)

12th European Multidisciplinary Congress on Urological Cancers 2020 (ESMO, ESTRO & EAU)

Pancreas Cancer Symposium 2020: Current and Future: Current and Future (Memorial Sloan Kettering)

ESMO Asia Congress 2020

21st Annual Meeting of the Society of Urologic Oncology

2020 Multidisciplinary Thoracic Cancers Symposium (ASCO, ASTRO, SITC & STS)

62nd ASH Annual Meeting and Exposition

San Antonio Virtual Breast Cancer Symposium (SABCS)

ESMO Immuno-Oncology Congress 2020

ESMO Immuno-Oncology Congress 2020

19th International Symposium on Pediatric Neuro-Oncology (ISPNO 2020)

NRG Oncology Semiannual Meeting

ESMO Targeted Anticancer Therapies Congress 2021 (TAT 2021)

17th St. Gallen International Breast Cancer Conference 2021

European Lung Cancer Congress 2021 (ELCC)

HOPA's 17th Annual Conference (Hematology/Oncology Pharmacy Association)

ESMO Breast Cancer 2021

ESMO World Congress On Gastrointestinal Cancer 2021

ESMO Congress 2021

ESMO Congress 2021

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Editorial Board Comments

OBR Finance