Industry News

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

Imfinzi Assigned Unique HCPCS Code for Reimbursement by CMS

Effective for dates of services on or after January 1, 2019, the following code can be used to identify Imfinzi (durvalumab, AstraZeneca) when billing across settings of care as noted in the Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs:
- J9173: Injection, durvalumab, 10 m
Read the full CY 2019 OPPS Final Rule here.

Posted 11/20/2018

FDA Approves Pembrolizumab for Hepatocellular Carcinoma
On November 9, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Read the Merck press release here.

Posted 11/12/2018

FDA Approves Elotuzumab, Pomalidomide, Dexamethasone for Multiple Myeloma
On November 6, Bristol-Myers Squibb Company announced that the Food and Drug Administration approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Read the Bristol-Myers Squibb press release here.

Posted 11/7/2018

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 Pembrolizumab for First-Line Treatment of Metastatic Squamous NSCLC
On October 30, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

Read the full FDA press release here.

Posted 10/31/2018

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 Expands Approval of HPV Vaccine to People Aged 27 to 45
On October 5, the U.S. Food and Drug Administration expanded the approved use of Gardasil 9 (Human Papillomavirus [HPV] 9-valent Vaccine, Recombinant, Merck & Co.) to include individuals aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by nine types of HPV. Gardasil 9 was previously approved for individuals aged 9 through 26 years.

Read the full FDA press release here.

Posted 10/8/2018

Imfinzi Demonstrates Overall Survival Benefit in Stage III Lung Cancer

AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi (durvalumab) during the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Toronto, Canada. Results were published simultaneously in the New England Journal of Medicine.

Results from the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following chemoradiation showed that Imfinzi significantly improved OS, the second primary endpoint of the trial, compared to placebo regardless of PD-L1 expression, reducing the risk of death by 32%.

Read the full corporate press release here.

Posted 9/28/18