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

Taiho Oncology Patient Support Program

Taiho Oncology Patient Support^™ offers personalized services to give patients, caregivers, and healthcare professionals the help they need in getting started with Taiho Oncology Products. This includes insurance verification, help with medication costs, and treatment plan support.

Learn more. 

Posted 6/22/2020

Lonsurf Efficacy Flashcard

Lonsurf^®  (FTD/TPI, Taiho Oncology) is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.


Read efficacy and safety information. 

Posted 6/22/2020

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 West Virginia.
 
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

CMS Issues Product-Specific J-code for Adakveo®

Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg.

The new and unique J-code replaces all previous HCPCS codes for crizanlizumab-tmca (Adakveo^®, Novartis) for IV Infusion 10 mg/mL. The permanent J-code is used by all payer types.

Please note: For dates of service before July 1, 2020, use either J3490 (unclassified drugs, all sites of care) or J3590 (unclassified biologics, all sites of care). For dates of service between April 1, 2020, and June 30, 2020, some payers may allow the use of C9053 (injection, crizanlizumab-tmca, 1 mg, hospital outpatient).

See full prescribing information.

Posted 6/12/20

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