FDA Approves Pralsetinib for RET-Altered Thyroid Cancers

On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved pralsetinib for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Read the FDA announcement.

Read Genentech's announcement.

Posted 12/2/2020

FDA Issues EUA for Casirivamab + Imdevimab Antibodies to Treat COVID-19

On November 21, 2020, the U.S. Food and Drug Administration (FDA) announced its second emergency use authorization (EUA) for monoclonal antibodies to treat COVID-19. Under the EUA, casirivamab and imdevimab must be administered together by intravenous use for the treatment of mild to moderate COVID-19 in adults and pediatric patients who:

• Are 12-years-old or older

• Weigh at least 40 kilograms (about 88 pounds)

• Have positive results of direct SARS-CoV-2 viral testing

• Are at risk for progressing to severe COVID-19*.

*This includes those who are 65 years of age or older or who have certain chronic medical conditions.

When administered together in patients with COVID-19 via clinical trial, casirivamab and imdevimab reduced COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. A benefit has not been shown in patients hospitalized due to COVID-19. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.

Read the FDA announcement.

Posted 11/23/2020

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

CMS to Release Permanent J-Code for Phesgo™ Injection

Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo™, Genentech) injection for subcutaneous use will be issued a permanent J-Code that can be used starting January 1, 2021.

This single code (J9316) is to be used for all PHESGO patients and dosage strengths. 

Indications

Early Breast Cancer 
Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with chemotherapy for

• The neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer (EBC); and

• The adjuvant treatment of adult patients with HER2-positive early breast cancer (EBC) at high risk of recurrence.

Select patients for therapy based on an FDA-approved companion diagnostic test.

Metastatic Breast Cancer  
Phesgo™ is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic test.

See prescribing information.

Posted on 11/19/2020

FDA Approves Pembrolizumab + Chemotherapy for TNBC

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 Accepts for Priority Review Cemiplimab-rwlc for Advanced NSCLC

On Thursday, October 29, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor cemiplimab-rwlc (Libtayo^®, Regeneron Pharmaceuticals, Inc.) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.

The target action date for the FDA decision is February 28, 2021.

Read press release. 

Posted on 10/29/2020.

FDA Approves Venetoclax in Combination for Untreated AML

On October 16, 2020, the U.S. Food and Drug Administration (FDA) granted regular approval to Venclexta® (venetoclax) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy.

Venetoclax was initially granted accelerated approval for this indication in November 2018.

Read Roche's announcement and the FDA announcement.

Posted 10/19/2020

FDA Approves Expanded Indication of Pembrolizumab for R/R cHL

Ibrutinib for the Treatment of Adult Patients with CLL/SLL

Read efficacy study and prescribing information. 

To help guide and assist patients during treatment, Pharmacyclics the YOU&i^TM Support Program, which provides information on insurance coverage and out-of-pocket costs, and what to expect while on treatment.

Posted on 10/07/2020