Latest FDA Approval

• June 26, 2024- FDA grants accelerated approval to epcoritamab-bysp for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
• June 21 - FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer
• June 17 - FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma
• June 14 - FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia
• June 14 - FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer
• June 12 - FDA approves selpercatinib for RET fusion-positive thyroid cancer
• June 6 - FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia
• May 29 - FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors
• May 16 - FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
  
• May 15 - FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
  
• April 29 - FDA granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.  [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 
• April 23 - FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
• April 23 - FDA granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
  
• April 22 - FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
  
• April 18 - FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer | FDA
• April 5 - FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

Package/Label Updates

Code Updates

• Effective for dates of service on or after April 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has assigned the following Healthcare Common Procedure Coding System (HCPCS)* J-Code for ELREXFIO (elranatamab-bccm) injection:
  

Other Updates