Bristol-Myers Squibb relatlimab for the treatment of melanoma

In 2021, the U.

The U.
S.
FDA has approved BMS Class 2 checkpoint inhibitors
.
By mid-March, the third category
may be approved.
Currently, the agency is reviewing BMS's in-research immunotherapy, relatlimab
.
The drug targets early immune checkpoint inhibitors from BMS and other companies (e.
g.
, Merck, Roche, Renewable), which work by blocking CTLA-4, PD-1, or PD-L1 proteins, while relatlimab acts on a protein
called LAG-3.
However, the mechanism behind these drugs is similar: by blocking these proteins, anti-cancer immune cells are helped target and attack tumor cells
.

Approval of relatlimab is important both in the field of immunotherapy and BMS
.
In the field of immunotherapy, years have previously been spent looking for additional ways to unlock the immune system's ability to
fight cancer.
For BMS, the company has lost its early market advantage
over Merck.

The FDA will review Relatlimab on March 19
.
Clinical trials have shown that in patients with melanoma that has spread or cannot be surgically removed, relatlimab + Opdivo dual immunotherapy significantly reduces the risk of
cancer progression compared with Opdivo monotherapy.
This result is the first time that targeting LAG-3 has been clearly demonstrated to be beneficial, and the first time that a protocol can provide improved results
compared to Opdivo.

3.
Gilead lenacapavir for HIV

Gilead has maintained an industry-leading business
in HIV treatment for many years.
In the first nine months of 2021 alone, the company's HIV business generated about $11.
8 billion in sales
.
However, due to competition from strong rivals such as Merck, Johnson & Johnson and GlaxoSmithKline, Gilead is still under pressure
to innovate.
In this regard, a drug called lenacapavir becomes very important
for Gilead's future.

lenacapavir is a potentially pioneering long-acting HIV-1 capsid inhibitor that inhibits HIV-1 replication by interfering with several important steps in the viral life cycle, including capsid-mediated uptake of HIV-1 previral DNA, assembly and release of the virus, and formation
of the capsid core.

Gilead has achieved positive clinical trial results: lenacapavir has shown significant efficacy in patients with MDR-resistant HIV who have tried multiple other therapies and are no longer effective
.
Of the patients treated to date, approximately 80% of patients achieved an undetectable viral load after 6 months of treatment with lenacapavir and an optimized background regimen
.

Based on these results, Gilead filed a listing application for
lenacapavir with the U.
S.
FDA last summer.
The FDA expects to make a review decision
on February 28.
If approved, lenacapavir would be the first ever capsid inhibitor to be marketed and the only HIV treatment option
to be administered every 6 months.

4.
Akabegia vadadustat for renal anemia

Not long ago, a group of oral drugs known as HIF-PH inhibitors were considered the next important drug
for treating anemia in patients with chronic kidney disease.
But their potential as a convenient and safe alternative to injectable drugs such as Aranesp has dimmed
.

In 2020, vadadustat, a drug from Akebia Therapeutics, appears to be worse
than Aranesp in terms of cardiac safety in a Phase 3 clinical trial.
Subsequently, the FDA and its advisory board rejected FibroGen's drug of the same type, roxadustat, which has been approved
in several other countries.
The FDA and its advisory board have expressed concern about
the cardiovascular risks of roxadustat.
Since then, Faber has restructured, while Akebia's stock trading is at an all-time
low.

However, HIF-PH inhibitors still have a future in the
United States.
Last November, GlaxoSmithKline announced detailed positive results from a Phase 3 clinical trial of daprodustat, which was also approved
outside the United States.
Akebia, for its part, filed a listing application despite setbacks, claiming that its full findings were sufficient to ensure regulatory approval
.

That belief will be tested
this quarter.
While analysts have been skeptical that the drug can be approved in the broadest population of people with chronic kidney disease, some believe the FDA will approve the drug for dialysis patients, who still represent a considerable market
.
The FDA will make a decision
by March 29.

5.
AstraZeneca/Merck Lynparza for the treatment of early breast cancer

Lynparza, an anti-cancer drug known as a PARP inhibitor, is an industry leader in its class, has received regulatory approval in multiple tumor types, and in the process has become a multibillion-dollar drug
.
However, if the FDA approves it for the early treatment of a particularly aggressive hereditary breast cancer, the drug's biggest impact to date could soon come
.

In a Phase 3 trial last year, Lynparza adjuvant therapy reduced the risk
of cancer recurrence in patients with BRCA1 or BRCA2 mutation HER2-negative early breast cancer who had completed topical therapy and standard neoadjuvant or adjuvant chemotherapy.
BRCA1 and BRA2 are two gene mutations that account for about 5%
of all breast cancer cases.

Experts who were not affiliated with the study and were interviewed by BioPharma Dive said the findings have the potential to change clinical practice
.
But key questions remain, most notably how long Lynparza will be able to extend its lifespan and whether the advent of the drug will encourage BRCA testing
.
If approved, Lynparza will also be the latest high-priced anticancer drug to enter the earlier treatment of cancer, which is widely seen as a very lucrative market opportunity for
Lynparza.