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FDA Approves Nivolumab Plus Ipilimumab And Chemotherapy...

(FDA.gov) May 27, 2020 - On May 26, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb...

New Analysis Shows Survival Benefit Of Novartis' Kisqali

(PharmaTimes [UK]) May 27, 2020 - Novartis says a new exploratory subgroup analysis of the Phase III MONALEESA-3 and MONALEESA-7 trials reinfo...

Exclusive: Research Finds Concerning Drop In U.S. Color...

(Reuters) May 27, 2020 - New diagnoses of one of the deadliest cancers fell by one-third in March and April as U.S. physicians and patients ha...

Featured Content

Sibel Blau, MD, shares examples of applied informatics being incorporated into patient management

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and BJ Rimel, MD, Assistant Professor, Obstetrics and Gynecology, Cedars-Sinai Medical Center, discuss recent clinical studies in ovarian cancer and how recent developments are impacting the way ovarian cancer patients are treated.

At the AACR Virtual Meeting I, there was pivotal data from a trio of immunotherapy triplet trials in breast cancer (I-SPY 2), melanoma (IMSpire150), and prostate cancer (IMbassador250) — not all of which were successes. In addition, we report on a significant proof of principle study with a new TIL in PD-1 naive NSCLC patients, and look at Compugen’s ...

The emergence of COVID-19 has transformed the clinical care of cancer patients and upended the way oncology practices do business. During COA 2020, virtual presenters discussed the pandemic's impact on community oncology, including the role of telehealth in bridging the crisis, the financial fallout of COVID-19, and the lessons oncologists hope are take-a...

A recent FDA workshop delved into liquid biopsy screening approaches as they are increasingly being applied, particularly in the early detection of cancer. In addition, three high-profile cancer screening studies, Circulating Cell-free Genome Atlas (aka CCGA), DETECT-A, and TRACERx, stole the show at AACR's first Virtual Meeting.

At COA's first virtual Community Oncology Conference, presenters across the country discussed modernizing the clinical trial process, navigating the complexity of cancer care with applied informatics, and improving value-based reimbursement. Virtual sessions on oncology payment reform covered updates on the OCM 1.0, an OCM 2.0 in the works, and the laun...

Podcasts

Ovarian Cancer - BJ Rimel, MD, and Robert Figlin, MD, discuss recent studies and FDA approvals in ovarian cancer

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Renal Cell Carcinoma (RCC) – Tian Zhang, MD, and Robert Figlin, MD, discuss recent clinical advances in RCC fro...

03/20/20

Prostate Cancer – Daniel Petrylak, MD, and Robert Figlin, MD, discuss recent clinical advances in prostate canc...

03/02/20

Colorectal Cancer – Zev Wainberg MD, and Robert Figlin, MD, discuss recent clinical advances in colorectal canc...

02/12/20

Mantle Cell Lymphoma (MCL) – Michael Wang MD, and Robert Figlin, MD, discuss recent clinical advances in mantle...

02/03/20

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Lee Schwartzberg, MD, FACP, on whether clinical trial experience with I-O translates to routine care

Thomas Sonderberg, on the needs of small to midsize employers compared to larger employers with more contract leverage

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May 2020 Edition

At COA's first virtual Community Oncology Conference, presenters across the country discussed modernizing the clinical trial process, navigating the complexity of cancer care with applied...

May 2020 Edition

The emergence of COVID-19 has transformed the clinical care of cancer patients and upended the way oncology practices do business. During COA 2020, virtual presenters discussed the pandem...

May 2020 Edition

A recent FDA workshop delved into liquid biopsy screening approaches as they are increasingly being applied, particularly in the early detection of cancer. In addition, three high-profile...

May 2020 Edition

At the AACR Virtual Meeting I, there was pivotal data from a trio of immunotherapy triplet trials in breast cancer (I-SPY 2), melanoma (IMSpire150), and prostate cancer (IMbassador250) �...

Blog

Preview of Noteworthy Abstracts from the ASCO20 Virtual...

May 13, 2020

At a pre-meeting press conference, ASCO gave reporters a peek at some of the important presentations at the upcoming ASCO20 Virtual Scientific Program. The topi...

American Association for Cancer Research (AACR) 2020 Vi...

Apr 27, 2020

On April 23, 2020, the AACR held a preview press conference in advance of its first-ever Virtual Annual Meeting I taking place April 27 - 28, 2020, necessitated b...

New Telehealth Policies Ensuring Cancer Patients Aren&r...

Apr 07, 2020

I don’t have to tell anyone that the novel coronavirus has caused an unprecedented global crisis. However, with attention rightfully so on COVID-19, and the str...

OBR Tools

Stemming from the user preference that you set, stay informed and increase your productivity via 27/7 web based access to Ontellitrac 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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May 29 - May 31, 2020

Memorial Sloan Kettering 2nd Annual Palliative Care Symposium for Advanced Practice Providers [CANCELLED; POSTPOSED TIL 2021]

New York, NY

June 27 - 28, 2020

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
Jun 16	Merck, Keytruda® (pembrolizumab) Merck said on Apr. 7, 2020 that the FDA had accepted its sBLA seeking accelerated approval for Keytruda as monotherapy in patients whose tumors are tumor mutational burden-high (TMB-H) ≥10 mutations/megabase, and who have progressed following prior treatment. The FDA set a PDUFA date of June 16, 2020. The application was partially based on results from the phase 2 KEYNOTE-158 trial, which also supported the 2017 FDA approval for Keytruda as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. MSI-H is on the highest end of the TMB spectrum. Data from KEYNOTE-158 on the TMB-H patient population were presented at the ESMO 2019 Congress. Tissue TMB status was determined using the Foundation Medicine, Inc. FoundationOne® CDx assay.
Jun 18	Epizyme, Tazverik™ (tazemetostat) The company said on Feb. 14, 2020 that the FDA had accepted for filing and granted a priority review to its NDA for the accelerated approval of tazemetostat, an oral EZH2 inhibitor, for patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. The FDA designated the application as a supplemental NDA (sNDA) with a PDUFA target action date of June 18, 2020. The filing is based on safety and efficacy data from a phase 2 study of tazemetostat as a monotherapy in patients with FL, both with or without EZH2 activating mutations, who received at least two prior lines of systemic therapy. The primary endpoint of the study was objective response rate (ORR). In updated data reported at 2019 ASCO from two cohorts of the phase 2 study, tazemetostat treatment resulted in an objective response rate (ORR) of 69% for patients with an EZH2 mutation and 35% for patients with wild-type EZH2. Tazverik received accelerated approval from the FDA on Jan. 23, 2020 for epithelioid sarcoma. It was the first FDA approval for the Epizyme therapy, and also the first treatment option ever approved by U.S. regulators for that rare soft tissue sarcoma.
Jun 19	Roche , Tecentriq® (atezolizumab) Roche announced on Feb. 19, 2020 that the FDA had accepted the company’s sBLA and granted Priority Review for Tecentriq as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing. The sBLA is based on results from the phase 3 IMpower110 study, showing that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months) in people with high PD-L1 expression (TC3/IC3-WT). The PDUFA action date for a decision on the application is June 19, 2020.
Jun 23	Karyopharm Therapeutics , Xpovio® (selinexor) tablets Karyopharm announced on Feb. 19, 2020 that the FDA had accepted for filing its sNDA seeking accelerated approval for oral Xpovio, a first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL), not otherwise specified, who have received at least two prior therapies. The FDA granted a Priority Review to the application with a PDUFA, or target action date, of June 23, 2020 assigned. Xpovio has received both Orphan Drug and Fast Track designations from U.S. regulators for the DLBCL indication. The company said it also expects to submit a Marketing Authorization Application (MAA) to European regulators in 2020 requesting conditional approval for Xpovio in DLBCL. Xpovio received accelerated approval from the FDA in July 2019 in combination with dexamethasone as a treatment for patients with heavily pretreated multiple myeloma (MM). Karyopharm has also submitted an MAA to European regulators with a request for conditional approval of selinexor in the MM indication.
Jun 30	Samsung Bioepis Co., SB8 Samsung Bioepis Co. announced on Nov. 11, 2019 that the FDA had accepted for review the BLA for SB8, a biosimilar candidate referencing Roche's Avastin (bevacizumab). If approved, SB8 will be commercialized in the U.S. by Merck & Co. An approval decision is anticipated in Q2 2020.