Industry News

FDA Approves Pemetrexed for Metastatic NSCLC
On January 31, the U.S. Food and Drug Administration (FDA) approved pemetrexed for injection (Alimta, Eli Lilly and Company) in combination with pembrolizumab and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

Read the Eli Lilly and Company press release here.

Posted 1/31/2019

Medicare Coverage Established for MRD Testing for ALL, Multiple Myeloma
On January 17, Adaptive Biotechnologies announced that Palmetto GBA has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL). clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The article is effective immediately and enables national coverage of Medicare patients undergoing testing.

Read the Adaptive Biotechnologies press release here.

Posted 1/23/2019

CMS Assigns New J-Codes for Rituxan and Rituxan Hycela
Effective January 1, 2019, the Centers for Medicare & Medicaid Services (CMS) has assigned new J-codes for Rituxan and Rituxan Hycela (Genentech, Inc.):
- J9312: Injection, rituximab, 10 mg (replaces J-code J9310)
- J9311: Injection, rituximab 10 mg and hyaluronidase
These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements.

Read more about the new J-codes for Rituxan and Rituxan Hycela here.

Posted 12/7/2018

FDA Approves Atezolizumab for Metastatic NSq NSCLC
On December 6, 2018, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations.

Read FDA announcement.

Posted 12/7/2018

FDA Approves Venetoclax for Acute Myeloid Leukemia

On November 21, the Food and Drug Administration granted accelerated approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Read the full FDA press release here.

Posted 11/26/18

FDA Approves Glasdegib for Acute Myeloid Leukemia
On November 21, the Food and Drug Administration approved glasdegib (Daurismo, Pfizer Inc.) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

Read the full FDA press release here.

Posted 11/26/2018

FDA Approves Lorlatinib for ALK+ Metastatic NSCLC

On November 2, the FDA granted accelerated approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with ALK+ metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

Read the full FDA press release here.

Posted 11/5/2018

FDA Approves Talazoparib for gBRCAm HER2- Breast Cancer
On October 16, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.) for the treatment of patients with deleterious or suspected germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on the use of the FDA-approved companion diagnostic BRACAnalysis CDx (Myriad Genetics, Inc.).

Read the full FDA press release here.

Posted 10/16/18

FDA Approves Dacomitinib for Metastatic NSCLC
On September 27, the Food and Drug Administration approved dacomitinib tablets (Vizimpro, Pfizer Inc.) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Read the full FDA press release here.

Posted 9/28/18

FDA Approves Pembrolizumab + Chemotherapy for NSqNSCLC
On August 17, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.

Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.

Read the full FDA announcement here.

Posted 8/20/2018

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