Cemiplimab-rwlc for IV injection

Trade Name: Libtayo®
Company: Regeneron/Sanofi
Approval Dates/Comments: In February 2021, the US FDA approved cemiplimab-rwlc, a programmed cell death-1 (PD-1) inhibitor, as the first immunotherapy treatment indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted to treat patients with locally advanced BCC and accelerated approval was given for patients with metastatic BCC. Cemiplimab-rwlc targets the immune checkpoint receptor PD-1 on T-cells and has been demonstrated to block cancer cells from utilizing the PD-1 pathway to suppress T-cell activation.

HA-based dermal filler

Trade Name: Restylane® Defyne™
Company: Galderma

Approval Dates/Comments: The FDA approved this hyaluronic acid (HA) dermal filler in February 2021 for the augmentation and correction of mild to moderate chin retrusion for adults >21 years of age.

Tirbanibulin ointment 1%

Trade Name: Klisyri®
Company: Almirall/Athenex

Approval Dates/Comments: The FDA approved tirbanibulin in December 2020 for the topical treatment of actinic keratosis (AK) on the face or scalp. This novel, topical, first-in-class microtubule inhibitor potentially represents a significant advancement in the treatment of AK due to its short treatment protocol (once daily application for 5 days) and demonstrated efficacy and safety profile. Data from Phase 3 trials reported complete clearance of AK lesions at day 57 on treated face or scalp areas in a significantly higher number of patients vs. vehicle, and no patient withdrawals due to adverse events.

Anakinra for SC use

Trade Name: Kineret®
Company: Swedish Orphan Biovitrum (Sobi™)

Approval Dates/Comments: In December 2020, the FDA approved the supplemental Biologics License Application for anakinra, an interleukin (IL)-1 receptor antagonist, for the treatment of deficiency of IL-1 receptor antagonist (DIRA). DIRA is an ultra-rare, autoinflammatory disease caused by a genetic mutation in the IL1RN gene, which encodes the IL-1 receptor antagonist (IL-1Ra) protein. In patients with DIRA, the deficiency of IL-1Ra leads to uninhibited action of IL-1 signaling, resulting in life-threatening systemic inflammation with skin and bone involvement.

Immune modulatory vaccines for melanoma

Trade Name: IO102 and IO103
Company: IO Biotech

Approval Dates/Comments: The FDA granted Breakthrough Therapy designation in December 2020 for a combination of the potential therapy IO102 and IO103 with anti-PD-1 monoclonal antibody for patients with unresectable/metastatic melanoma. Both immune modulatory vaccines are based on IO Biotech’s proprietary T-win® technology platform, which enables the identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to robust anti-tumor responses without adding additional safety concern. The FDA’s decision was based on data from the MM1636 Phase 1/2 clinical trial with 30 patients with metastatic melanoma receiving IO102, IO10 and anti-PD-1. According to the data recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe; an overall response rate of 79% was reached and 45% of patients achieved a complete response, or complete disappearance of their tumors.

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