FDA APPROVALS

Bristol Myers Squibb announced that Orencia® (abatacept) was approved by the U.S. Food and Drug Administration (FDA) for the prophylaxis, or prevention, of acute graft versus host disease (aGvHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor (URD). More Information.

The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA expanded the indication for KEYTRUDA as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (12 years and older). More Information.

Before prescribing KEYTRUDA^® (pembrolizumab), please read the Prescribing Information. The Medication Guide also is available.

For prescribers: please click here for state-required price disclosures.

The U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS^® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX FASPRO^® (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.  More Information.

The Food and Drug Administration approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi Bioscience, Inc.) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).  More Information.

The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.  More Information.

Merck would like to inform you that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.   PD-L1 diagnostic testing is required prior to initiating treatment with KEYTRUDA in these patients.  More Information.

Novartis announced that the US Food and Drug Administration (FDA) approved Scemblix® (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. More Information.

Zanubrutinib has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) previously treated with at least one anti-CD20-based regimen.  More Information.

The Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. More information.

The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.  More Information.