FDA’s Next Move: Amgen, Alnylam, and BMS Await Game-Changing Decisions

In the fast-paced world of FDA decisions, the next two weeks promise to be a rollercoaster of anticipation. Brace yourselves for the verdicts on cutting-edge treatments.

Alnylam’s Onpattro in the battle against cardiomyopathy of ATTR, and Bristol Myers Squibb’s Opdivo, poised to make a groundbreaking impact in adjuvant melanoma, are both on the brink of judgment.

But before the final decisions are unveiled, the FDA is set to host a riveting advisory committee meeting. What’s on the docket? The spirited debate over Amgen’s Lumakras, a potential game-changer in the fight against non-small cell lung cancer. Stay tuned for a whirlwind of medical breakthroughs and pivotal decisions!

AdComm to Weigh Full Approval of Amgen’s Lumakras in NSCLC

Mark your calendars for October 5, when the FDA’s Oncologic Drugs Advisory Committee is set to convene for a momentous discussion. At the heart of this meeting is Amgen’s quest for full approval of Lumakras (sotorasib) in the realm of non-small cell lung cancer (NSCLC).

Lumakras made a splash when it clinched the FDA’s accelerated approval for NSCLC in May 2021. This game-changing oral inhibitor targets the notorious G12C-mutated KRAS, offering hope to patients battling locally advanced or metastatic disease, as determined by an FDA-approved test. A prerequisite? They must have already braved at least one prior line of systemic therapy.

But Amgen has been hard at work, amassing a trove of data to bolster Lumakras’ case for traditional approval. In September 2022, the company unveiled findings from the Phase III CodeBreaK 200 study, revealing Lumakras’ impressive prowess.

It not only charted a significantly improved path in progression-free survival but also showcased a remarkable overall response rate, outshining the competition – docetaxel.

Yet, the plot thickens. The crucial secondary endpoint, overall survival (OS), didn’t tip the scales significantly in Lumakras’ favor. But don’t be quick to judge, for CodeBreaK 200 wasn’t geared to unearth a statistical difference in OS, as an Amgen spokesperson clarified at the time.

Now, as we approach the FDA’s advisory committee meeting, the spotlight turns to the external experts. They’ll dissect the findings from CodeBreaK 200 and weigh Lumakras’ benefit-to-risk ratio, a pivotal step on the path to full approval. The FDA’s final verdict is slated to arrive, wrapped in anticipation, on or before December 24.

But the Lumakras story doesn’t end here. Amgen has ambitious plans, extending its reach to other solid tumor types, including colorectal cancer and small cell lung cancer. The journey of medical discovery continues, with Lumakras leading the way.

Alnylam Seeks Onpattro’s Expansion to Cardiomyopathy of ATTR

Mark your calendars for the imminent decision day, as the FDA gears up to reveal its verdict by October 8. Alnylam, the pioneering force behind the siRNA therapeutic Onpattro (patisiran), has submitted an sNDA, marking a pivotal moment in the world of medical innovation.

Onpattro first dazzled the scene in August 2018 when it clinched its maiden approval for tackling the relentless polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.

This rare and unforgiving condition is defined by the sinister buildup of misfolded transthyretin in vital organs, particularly the nerves. These rogue proteins don’t stop there; they infiltrate the heart, stiffening its walls and undermining its pumping prowess.

Alnylam’s bold sNDA move, accepted by the FDA in February 2023, seeks to expand Onpattro’s reach. The proposal? Elevate patisiran to a potent weapon against ATTR amyloidosis with cardiomyopathy.

The application is armed with compelling data from the Phase III APOLLO-B trial, a tale of transformation where patisiran emerges as the hero. It not only improved the quality of life for patients grappling with ATTR-cardiomyopathy but also boosted their functional capacity.

What’s more, the study delivered a resounding verdict on patisiran’s safety, with side effects mostly taking on a mild or moderate demeanor. The adverse events gracefully danced within the boundaries set by previous studies.

The plot thickens as we rewind to September 2023, when the FDA’s Cardiovascular and Renal Drugs Advisory Committee convened. In a decisive 9–3 vote, the committee rallied in favor of Alnylam, heralding patisiran’s favorable benefit-risk profile in this newfound battleground.

While the FDA isn’t bound by this advisory committee’s counsel, history often finds it walking in step with their recommendations.

Onpattro, the magical elixir of the future, is no ordinary remedy. This injectable double-stranded siRNA therapeutic wields its power by locking onto the mRNA molecule that holds the secrets of transthyretin.

A mark of doom is placed on this mRNA, leading to the ultimate demise of the protein, a strategic move that ushers in lower protein levels, and perhaps, brighter tomorrows.

BMS Bids to Bring Opdivo to an Earlier Melanoma Setting

The countdown to a critical decision is on, with the FDA poised to unveil its verdict on Bristol Myers Squibb’s groundbreaking supplemental Biologics License Application (sBLA) by October 13.

The proposal in question? Elevating Opdivo (nivolumab) to the ranks of adjuvant monotherapy for patients who have valiantly battled and emerged victorious from stage IIB or IIC melanoma.

Opdivo, already a stalwart in the realm of melanoma, earned its stripes back in December 2014. But the winds of change are stirring as BMS sets its sights on a new frontier – an earlier indication, one that could be a game-changer for patients.

Gina Fusaro, the Vice President and Development Program Lead at BMS, paints a vivid picture of the challenge at hand. “Patients with stage IIB or IIC melanoma walk a precarious tightrope, teetering on the edge of disease recurrence,” she declares.

The statistics loom ominously – approximately one-third of stage IIB and half of stage IIC patients grapple with the specter of recurrence within five years post-surgery.

BMS isn’t just making lofty claims; they’re armed with data from the heroic Phase III CheckMate -76K trial. This epic saga reveals Opdivo as the valiant protector, reducing the risk of recurrence or the cold clutches of death by a formidable 58% in patients with stage IIB or IIC disease.

The tale doesn’t end there; Opdivo-treated patients enjoy a higher recurrence-free survival rate over the span of 12 months.

But what of safety, you might wonder? Fear not, for CheckMate -76K’s vigilant gaze found no new signals of concern. Opdivo’s adverse event profile, as revealed in this saga, remains consistent with the harmonious tune struck in previous studies.

Opdivo isn’t content with resting on its laurels; it’s a versatile champion approved for a multitude of cancers, from NSCLC and head and neck squamous cell carcinoma to esophageal cancer, hepatocellular carcinoma, and renal cell carcinoma.

The journey continues, as BMS explores Opdivo’s therapeutic prowess, whether standing alone or in a harmonious symphony with other treatments, even in the earlier stages of disease. The battle against cancer rages on, with Opdivo at the forefront, a beacon of hope in the quest for healing.

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