myBeiGene™ Patient Support

The myBeiGene^™ patient support offers a customized and comprehensive support program designed to help guide and assist patients during treatment.

For more information or to enroll, click here. 

Posted 06/26/20

Astellas and Seattle Genetics Issue Product-Specific J-code for PADCEV

Astellas and Seattle Genetics are pleased to announce the assignment of a product-specific, permanent J-code for PADCEV. CMS released the July 2020 Quarterly Healthcare Common Procedural Coding System File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020. 

Read corporate announcement.

Posted 6/25/20

FDA Approves Pembrolizumab for Recurrent or Metastatic cSCC

On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Read the FDA announcement.

Posted 6/24/2020

FDA Approves Tabrecta for Metastatic NSCLC with METex14

On May 6, 2020, Novartis announced that the U.S. Food and Drug Administration (FDA) approved Tabrecta^TM (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Read corporate press release. 

Posted 6/22/2020

Pfizer Oncology Personalized Support

At Pfizer Oncology Together, patient support is at the core of everything they do. From helping to identify financial assistance options to connecting patients to resources for emotional support, the needs of patients prescribed Pfizer Oncology medications are a top priority.

Pfizer Oncology Field Reimbursement Managers (FRMs) can help address challenging or urgent Pfizer Oncology patient access cases. Click here for the FRM contact in Missouri.
 
Posted 6/22/2020

FDA Approves Pembrolizumab for Treatment of TMB-H Solid Tumors

On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

On the same day, the FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab.

Read the FDA announcement.

Posted 6/17/2020

FDA Extends Indication of Gemtuzumab Ozogamicin to CD33-Positive AML Pediatric Patients

On June 16, 2020, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg™, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older.

Read FDA announcement.

Posted 6/16/2020

FDA Approves HPV Vaccine Gardasil 9 for Prevention of Certain Head & Neck Cancers

On June 12, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.

Read the corporate press release.

Posted 6/15/2020

FDA Approves Atezolizumab for Adult Patients with Metastatic NSCLC

On May 18, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq^®, Genentech), as a single agent, for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1–stained ≥50% of tumor cells [TC ≥50%] or PDL1–stained tumor-infiltrating immune cells [IC] covering ≥10% of the tumor area [IC ≥10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. 

Read corporate announcement.

Read prescribing information. 

Posted 6/5/2020

FDA Approves Atezolizumab + Bevacizumab for Previously Untreated Advanced HCC

On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab in combination with bevacizumab (Tecentriq and Avastin, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Read full FDA announcement. 

Tecentriq prescribing information and billing/coding for HCC.

Avastin prescribing information and billing/coding for HCC.

Posted 6/2/2020