Industry News

FDA Approves Nivolumab + Cabozantinib for Advanced RCC

On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

Read Bristol Myers Squibb's announcement.

Read the FDA announcement.

Posted 1/22/2021

FDA Approves Crizotinib for Children and YA Patients with R/R ALCL

On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year of age and older and young adults (YA) with relapsed or refractory (R/R), systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

Read the FDA announcement.

Read Pfizer's announcement.

Posted 1/15/2021

FDA Approves Osimertinib for the Adjuvant Treatment of EGFRm NSCLC
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.

Read the FDA announcement.

Read AstraZeneca's announcement.

Posted 12/21/2020

Durvalumab Dosing Update

Durvalumab (Imfinzi^®, AstraZeneca) has been approved in the U.S. for an additional dosing option for patients with a body weight of 30 kg and more: 1500 mg administered intravenously every four weeks in the approved indication of unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy. Patients with body weight <30 kg must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks.

Read the press release.

Posted on 12/15/2020.

FDA Approves Additional Indication for Pembrolizumab

Pembrolizumab (Keytruda^®, Merck) has received FDA approval, in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD-L1) [combined positive score (CPS ≥10)] as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Select patients for treatment with KEYTRUDA in combination with chemotherapy based on the presence of positive PD-L1 expression in:
- locally recurrent unresectable or metastatic TNBC

Read prescribing information and Medication Guide.

Posted on 12/07/2020

Pfizer + BioNTech Announce EUA Request to FDA for COVID-19 Vaccine

On November 20, 2020, Pfizer and BioNTech announced that they have submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for BNT162b2, the companies’ COVID-19 mRNA vaccine candidate. If approved, some Americans could receive the vaccine as early as mid-December.

Through an accelerated clinical trial process, the potential vaccine demonstrated a 95 percent efficacy rate with no serious safety concerns to date. The companies expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion by the end of 2021.

The companies have also initiated rolling submissions with regulatory agencies around the world. Upon authorization, the companies state that they will be ready to distribute the vaccine within hours.

Read Pfizer's announcement. Find out more about Pfizer and BioNTech’s COVID-19 vaccine candidate from AP News, New York Times, and Washington Post.

Posted 11/20/2020

FDA Approves Pembrolizumab + Chemotherapy for TNBC
On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Keytruda® (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 (CPS ≥10) as determined by an FDA approved test.

Read the FDA announcement.

Read the Merck press release.

Posted 11/16/2020

Registration Open: Jakafi (ruxolitinib) Product Theater

Intervening With Jakafi^® (ruxolitinib) to Achieve Durable Count Control: Real-World Patient Case Discussion

Jakafi^® (ruxolitinib) is indicated for the treatment of patients with polycythemia vera who have had an inadequate response to—or are intolerant of—hydroxyurea; patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF; and for the treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Join a one-hour live presentation—sponsored by Incyte Corporation—to learn more about the use of Jakafi^® (ruxolitinib) in treating your patients.

Monday, November 30
12:00 - 1:00 PM EST

Presented by:
Solomon Hamburg, MD, PhD
Clinical Professor of Medicine, Division of Hematology-Oncology, Department of Medicine
UCLA Beverly Hills Hematology Oncology
REGISTER

Monday, November 30
3:00 - 4:00 PM EST

Presented by:
Jonathan Abbas, MD
Director, Acute Leukemia Program
Tennessee Oncology
REGISTER

FDA Approves Expanded Indication of Pembrolizumab for R/R cHL
On October 15, 2020, the U.S. Food and Drug Administration (FDA) approved an expanded label for Keytruda® (pembrolizumab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL). Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory cHL after frontline therapy.

Read Merck's press release and the FDA announcement.

Posted 10/15/2020

myBeiGene Patient Support for Zanubrutinib

Zanubrutinib (Brukinsa™, BeiGene) is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. For prescribing information click here, or here for the Dosing and Administration Guide.

To help guide and assist patients during treatment, Beigene has developed a customized and comprehensive support program. The myBeiGene Patient Support program is staffed with nurses who have prior experience working with oncology patients. Practices and their patients get a dedicated Oncology Nurse Advocate assigned to them, and comprehensive patient support, including connecting patients to helpful resources that can address their personal needs.

Posted on 10/07/2020

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