FDA Approves Tabrecta for Metastatic NSCLC with METex14
On May 6, 2020, Novartis announced that the U.S. Food and Drug Administration (FDA) approved TabrectaTM (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.
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 Wisconsin.
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.
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.
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.
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.
FDA Approves Nivolumab for Previously Treated Advanced Esophageal SCC
On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Read the FDA announcement.
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.
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.
FDA Approves Nivolumab+Ipilimumab Combo as 1st Line Treatment for Metastatic NSCLC
On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo, Bristol Myers Squibb Co.) plus ipilimumab (Yervoy, Bristol Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Read full FDA announcement.
Posted May 27, 2020